Chronic Total Occlusion (CTO), Coronary Artery Disease (CAD)
Conditions
Keywords
Angioplasty, Chronic Total Occlusion (CTO), Chronic total coronary occlusions, Coronary Artery Disease (CAD), Coronary artery stenosis, Total coronary occlusion
Brief summary
A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary Guide Wires, and MINI-TREK Coronary Dilatation Catheter in patients undergoing elective percutaneous revascularization of native chronic total coronary occlusions
Interventions
DEVICECTO Treatment Device
Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Subject is ≥ 18 years of age at the time of consent. 2. Subject is experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure, etc.) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization. 3. Subject is eligible and consents to undergo percutaneous coronary intervention (PCI procedure). 4. Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG). 5. Subject is willing and able to sign an informed consent form (ICF) approved by a local Institutional Review Board/Ethics Committee and to follow the protocol with up to 5-year follow up. 6. Female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before enrollment and effective birth control must be used up to 1 year following the index procedure. Angiographic Inclusion Criteria 1. A maximum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. A chronic total occlusion is any non-acute total coronary occlusion fulfilling the following angiographic characteristics and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram: * High-grade native coronary stenosis * TIMI 0 or 1 antegrade flow 2. Occluded segment suitable for placement of coronary stents: * Segment without severe tortuosity (angulation ≥ 45º) * Segment not located in an excessively distal location General
Exclusion criteria
Candidates will be excluded from the study if any of the following conditions are present: 1. Patients with any history of allergy to iodinated contrast that cannot be effectively managed medically, or any known allergy to clopidogrel bisulfate (Plavix®), aspirin, heparin, stainless steel, or everolimus 2. Evidence of acute myocardial infarction (MI) within 72 hours of the intended treatment (defined as: Q-wave or non-Q-wave MI having creatine kinase (CK) enzymes 2 × the upper limit of normal (ULN) with the presence of a creatine kinase myocardial-band isoenzyme (CK-MB) above the Institution's ULN, or troponin (I or T) above the Institution's ULN) 3. Previous coronary interventional procedure of any kind within the 30 days prior to the procedure in the target vessel 4. Planned interventional treatment of either the target or any non-target vessel within 30 days post-procedure 5. Planned interventional treatment of either the target or any non-target vessel within 6 months post-procedure with any alternative drug eluting stent (DES) (e.g., CYPHER Sirolimus-Eluting stent, TAXUS Paclitaxel-Eluting stent or Endeavor Zotarolimus-Eluting Endeavor stent) 6. Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, unfractionated heparin) 7. Target lesion requires treatment with a device after successful crossing other than PTCA prior to stent placement (including, but not limited to directional or rotational coronary atherectomy, excimer laser, thrombectomy, etc.). Note: Use of alternative technologies to conventional guide wires that are approved by the United States Food and Drug Administration for CTO revascularization (e.g., Asahi Tornus and Corsair catheters, IntraLuminal Therapeutics Safe Cross guide wire, Flowcardia CROSSER system) is permitted and will be collected in the case report form. 8. Patients with history of clinically significant abnormal laboratory findings including: * Neutropenia (\<1000 neutrophils/mm3) within the previous 2 weeks, or * Thrombocytopenia (\<100,000 platelets/mm3), or * Aspartate Transaminase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase, or bilirubin \> 1.5 × ULN, or * Serum creatinine \> 1.5 mg/dL 9. Patients with evidence of ongoing or active clinical instability including the following: * Sustained systolic blood pressure \< 100 mmHg or cardiogenic shock * Acute pulmonary edema or severe congestive heart failure * Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade * Suspected dissecting aortic aneurysm * Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease 10. Target lesion involves a bifurcation including a diseased side branch ≥2.25 mm in diameter that would require treatment 11. Target vessel with a patent bypass graft from prior coronary bypass surgery 12. Proximal coronary stenting of target lesion 13. History of stroke or transient ischemic attack within the prior 6 months 14. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months 15. History of bleeding diathesis or coagulopathy or refusal of blood transfusions 16. Patients with any other pathology such as cancer, mental illness, etc., which in the opinion of the Investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study. 17. Known previous medical condition yielding expected survival less than 1 year. 18. Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements. 19. Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (IVUS), or other coronary artery imaging procedures Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set) | 1 year | The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter. |
| Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set) | 1 year | The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter. |
| Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI) | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on ARC MI (component 2) |
| Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI) | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on protocol MI (component 2) |
| Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | 1. Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and; 2. Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and; 3. Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and; 4. Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Defined as device success and absence of in-hospital MACE with antegrade crossing technique |
| Percentage of Participants With Procedural Success With Knuckle Wire | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Defined as device success and absence of in-hospital MACE with antegrade crossing technique |
| Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Defined as device success and absence of in-hospital MACE with antegrade crossing technique |
| Percentage of Participants With Procedure Success | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Device success and absence of in-hospital MACE. Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves). Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment. |
| Percentage of Participants With Procedural Success With Antegrade Crossing | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Defined as device success and absence of in-hospital MACE with antegrade crossing technique. |
| Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART) | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Defined as device success and absence of in-hospital MACE with antegrade crossing technique |
| Percentage of Participants With Procedural Success With Reverse CART | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Defined as device success and absence of in-hospital MACE with antegrade crossing technique |
| Percentage of Participants With Procedural Success With Kissing Wire Technique | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Defined as device success and absence of in-hospital MACE with antegrade crossing technique |
| Percentage of Participants With Procedural Success With Sub Intimal Technique | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Defined as device success and absence of in-hospital MACE with antegrade crossing technique. |
| Percentage of Participants With Procedural Success With Multiple Crossing Techniques | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Defined as device success and absence of in-hospital MACE with antegrade crossing technique |
| Resource Utilization: Procedural Time | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | — |
| Resource Utilization: Fluoroscopic Time | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | — |
| Resource Utilization: Contrast Volume | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | — |
| Minimum Lumen Diameter (MLD): Pre-procedure | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory. |
| Number of Participants With Major Adverse Cardiac Events (MACE) | 30 days | Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization. |
| Number of Participants Experiencing Death | 30 days | MACE Component; per protocol. Death is divided into 2 categories: Cardiac death is defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded. Non-cardiac death is defined as a death not due to cardiac causes (as defined above). |
| Number of Participants Experiencing Cardiac Death | 30 days | TLF component. Cardiac death was defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded |
| Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI) | 30 days | MACE Component; Myocardial Infarction (per ARC definition) * Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal * Non-Q-wave MI: All MIs not classified as Q-wave. |
| Number of Participants With Target Vessel-related MI | 30 days | TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. |
| Number of Participants With Target Lesion Revascularization (TLR) | 30 days | Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site. |
| Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) | 30 days | TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study. |
| Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR) | 1 year | TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study. |
| Number of Participants With All Target Vessel Revascularization (TVR) | 30 days | Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \>= 70% by QCA without either angina or a positive functional study |
| Number of Participants With Target Vessel Failure (TVF) | 30 days | Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when any of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined. |
| Number of Participants With Target Lesion Failure (TLF) | 30 days | Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol. |
| Number of Participants With Stent Thrombosis | Acute (0-24 hours) | Academic Research Consortium (ARC) criteria; definite and probable Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause. |
| Number of Participants With Occurrence of Stent Fracture at Target Lesion | 1 year | Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up. |
| Percentage of Participants With Clinically Significant Perforation | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy |
| Minimum Lumen Diameter (MLD): Post-procedure | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Laboratory. |
| Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. TIMI Classification: TIMI 0 No perfusion. TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run. TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel. TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds. |
| Percentage of Participants With Change in TIMI Flow Grade: Post-procedure | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. TIMI Classification: TIMI 0 No perfusion. TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run. TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel. TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds. |
| Percentage of Participants With Device Success | Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes | Achievement of \<50% diameter stenosis within the target lesion segment using assigned study device |
Countries
United States
Participant flow
Recruitment details
A total of 250 subjects were enrolled in 20 sites from September 13, 2011 to February 7, 2013. Twenty-eight participants were excluded from ITT (N=222) in whom recanalization and pre-dilatation of the target lesion were not completed and/or study stent was not inserted into the coronary guiding catheter.
Pre-assignment details
ITT set included 222 subjects who met entry criteria, were enrolled in the trial and whose target lesion was successfully crossed and predilated. PP set included all ITT subjects (N = 183) in whom at least 1 study stent was implanted,met procedure success,had follow-up data and had no major protocol deviations due to inappropriate enrollment.
Participants by arm
| Arm | Count |
|---|---|
| CTO Treatment Subjects receiving at least 1 of the following for the treatment of CTO:
* XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
* HT PROGRESS and/or HT PILOT guide wires in recanalization
* MINI-TREK Coronary Dilatation Catheter in predilatation
CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:
* XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
* HT PROGRESS and/or HT PILOT guide wires in recanalization
* MINI-TREK Coronary Dilatation Catheter in predilatation | 222 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| ITT at 1 Month | Death | 1 |
| ITT at 1 Month | Lost to Follow-up | 4 |
| ITT at 1 Month | Withdrawal by Subject | 1 |
| ITT at 1 Year | Death | 1 |
| ITT at 1 Year | Lost to Follow-up | 6 |
| ITT at 1 Year | Withdrawal by Subject | 2 |
| ITT at 2 Years | Death | 7 |
| ITT at 2 Years | Lost to Follow-up | 4 |
| ITT at 2 Years | Withdrawal by Subject | 2 |
| ITT at 3 Years | Death | 5 |
| ITT at 3 Years | Lost to Follow-up | 4 |
| ITT at 3 Years | Withdrawal by Subject | 2 |
| ITT at 4 Years | Death | 4 |
| ITT at 4 Years | Lost to Follow-up | 1 |
| ITT at 4 Years | Withdrawal by Subject | 2 |
| ITT at 6 Months | Death | 2 |
| ITT at 6 Months | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | CTO Treatment |
|---|---|
| Age, Continuous | 61.65 years STANDARD_DEVIATION 10.43 |
| Clinical Characteristics Atrial fibrillation | 14 participants |
| Clinical Characteristics Cancer | 4 participants |
| Clinical Characteristics Congestive Heart Failure | 27 participants |
| Clinical Characteristics Diabetes Mellitus | 89 participants |
| Clinical Characteristics Dyslipidemia | 215 participants |
| Clinical Characteristics History of bleeding | 18 participants |
| Clinical Characteristics Hypertension | 203 participants |
| Clinical Characteristics Mental Illness | 5 participants |
| Clinical Characteristics Previous Percutaneous Intervention (PCI) | 96 participants |
| Clinical Characteristics Prior Coronary Artery Bypass Graft Surgery | 22 participants |
| Clinical Characteristics Prior Myocardial Infarction (MI) | 61 participants |
| Clinical Characteristics Renal Insufficiency/failure | 1 participants |
| Clinical Characteristics Stroke | 2 participants |
| Clinical Characteristics Transient Ischemic Attack (TIA) | 3 participants |
| Number of diseased vessels Double | 38 participants |
| Number of diseased vessels Single | 170 participants |
| Number of diseased vessels Triple | 14 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 178 Participants |
| Region of Enrollment United States | 222 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 180 Participants |
| Tobacco use Current or former, quit within the past month | 54 participants |
| Tobacco use Former user, quit more than 1 month ago | 89 participants |
| Tobacco use Never used tobacco | 65 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 222 |
| other Total, other adverse events | 141 / 222 |
| serious Total, serious adverse events | 92 / 222 |
Outcome results
Primary
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)
The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.
Time frame: 1 year
Population: Intention-to-treat (ITT) definition: ITT subjects include all subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and whose target lesion was successfully crossed and predilated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set) | 39 Participants |
Primary
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)
The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.
Time frame: 1 year
Population: Per-protocol (PP) definition: The per-protocol population is defined as all ITT subjects in whom at least 1 study stent was implanted, met procedure success, had available follow up data (i.e. a MACE event within 360 days or follow up of at least 330 days), and did not have major protocol deviations due to inappropriate enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set) | 15 Participants |
Primary
Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO
1. Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and; 2. Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and; 3. Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and; 4. Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: Angiographically Evaluable Subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO | 93.8 percentage of participants |
Primary
Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)
Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on ARC MI (component 2)
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTO Treatment | Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI) | Guide Wire-related Endpoint | 79.0 percentage of participants |
| CTO Treatment | Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI) | Component 1 | 89.9 percentage of participants |
| CTO Treatment | Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI) | Component 2 | 89.1 percentage of participants |
Primary
Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)
Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on protocol MI (component 2)
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTO Treatment | Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI) | Guide Wire-related Endpoint | 87.7 percentage of participants |
| CTO Treatment | Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI) | Component 1 | 89.9 percentage of participants |
| CTO Treatment | Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI) | Component 2 | 97.8 percentage of participants |
Secondary
Minimum Lumen Diameter (MLD): Post-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Laboratory.
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CTO Treatment | Minimum Lumen Diameter (MLD): Post-procedure | In-Segment | 1.85 mm | Standard Deviation 0.47 |
| CTO Treatment | Minimum Lumen Diameter (MLD): Post-procedure | In-Stent | 2.32 mm | Standard Deviation 0.39 |
Secondary
Minimum Lumen Diameter (MLD): Pre-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory.
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CTO Treatment | Minimum Lumen Diameter (MLD): Pre-procedure | 0.01 mm | Standard Deviation 0.05 |
Secondary
Number of Participants Experiencing Cardiac Death
TLF component. Cardiac death was defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Cardiac Death | 2 Participants |
Secondary
Number of Participants Experiencing Cardiac Death
TLF component. Cardiac death was defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded
Time frame: 30 days
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Cardiac Death | 1 Participants |
Secondary
Number of Participants Experiencing Cardiac Death
TLF component. Cardiac death was defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Cardiac Death | 10 Participants |
Secondary
Number of Participants Experiencing Cardiac Death
TLF component. Cardiac death was defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Cardiac Death | 8 Participants |
Secondary
Number of Participants Experiencing Cardiac Death
TLF component. Cardiac death was defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Cardiac Death | 5 Participants |
Secondary
Number of Participants Experiencing Cardiac Death
TLF component. Cardiac death was defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded
Time frame: 6 months
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Cardiac Death | 1 Participants |
Secondary
Number of Participants Experiencing Death
MACE Component; per protocol. Death is divided into 2 categories: Cardiac death is defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Death | 4 Participants |
Secondary
Number of Participants Experiencing Death
MACE Component; per protocol. Death is divided into 2 categories: Cardiac death is defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time frame: 30 days
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Death | 1 Participants |
Secondary
Number of Participants Experiencing Death
MACE Component; per protocol. Death is divided into 2 categories: Cardiac death is defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Death | 20 Participants |
Secondary
Number of Participants Experiencing Death
MACE Component; per protocol. Death is divided into 2 categories: Cardiac death is defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Death | 16 Participants |
Secondary
Number of Participants Experiencing Death
MACE Component; per protocol. Death is divided into 2 categories: Cardiac death is defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Death | 11 Participants |
Secondary
Number of Participants Experiencing Death
MACE Component; per protocol. Death is divided into 2 categories: Cardiac death is defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time frame: 6 months
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants Experiencing Death | 3 Participants |
Secondary
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \>= 70% by QCA without either angina or a positive functional study
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With All Target Vessel Revascularization (TVR) | 21 Participants |
Secondary
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \>= 70% by QCA without either angina or a positive functional study
Time frame: 30 days
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With All Target Vessel Revascularization (TVR) | 2 Participants |
Secondary
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \>= 70% by QCA without either angina or a positive functional study
Time frame: 6 months
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With All Target Vessel Revascularization (TVR) | 6 Participants |
Secondary
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \>= 70% by QCA without either angina or a positive functional study
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With All Target Vessel Revascularization (TVR) | 22 Participants |
Secondary
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \>= 70% by QCA without either angina or a positive functional study
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With All Target Vessel Revascularization (TVR) | 24 Participants |
Secondary
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \>= 70% by QCA without either angina or a positive functional study
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With All Target Vessel Revascularization (TVR) | 15 Participants |
Secondary
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study.
Time frame: 30 days
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) | 2 Participants |
Secondary
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study.
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) | 20 Participants |
Secondary
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study.
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) | 19 Participants |
Secondary
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study.
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) | 18 Participants |
Secondary
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study.
Time frame: 6 months
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) | 5 Participants |
Secondary
Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study.
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR) | 13 Participants |
Secondary
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Major Adverse Cardiac Events (MACE) | 44 Participants |
Secondary
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Major Adverse Cardiac Events (MACE) | 37 Participants |
Secondary
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Major Adverse Cardiac Events (MACE) | 21 Participants |
Secondary
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Time frame: 30 days
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Major Adverse Cardiac Events (MACE) | 8 Participants |
Secondary
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Time frame: 6 months
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Major Adverse Cardiac Events (MACE) | 13 Participants |
Secondary
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 720 days or ITT subjects with follow-up of at least 690 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Major Adverse Cardiac Events (MACE) | 32 Participants |
Secondary
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component; Myocardial Infarction (per ARC definition) * Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal * Non-Q-wave MI: All MIs not classified as Q-wave.
Time frame: 30 days
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI) | 24 Participants |
Secondary
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component; Myocardial Infarction (per ARC definition) * Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal * Non-Q-wave MI: All MIs not classified as Q-wave.
Time frame: 6 months
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI) | 26 Participants |
Secondary
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component; Myocardial Infarction (per ARC definition) * Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal * Non-Q-wave MI: All MIs not classified as Q-wave.
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI) | 29 Participants |
Secondary
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component; Myocardial Infarction (per ARC definition) * Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal * Non-Q-wave MI: All MIs not classified as Q-wave.
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI) | 31 Participants |
Secondary
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component; Myocardial Infarction (per ARC definition) * Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal * Non-Q-wave MI: All MIs not classified as Q-wave.
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI) | 34 Participants |
Secondary
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component; Myocardial Infarction (per ARC definition) * Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal * Non-Q-wave MI: All MIs not classified as Q-wave.
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI) | 37 Participants |
Secondary
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 720 days or ITT subjects with follow-up of at least 690 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Occurrence of Stent Fracture at Target Lesion | 0.0 Participants |
Secondary
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Occurrence of Stent Fracture at Target Lesion | 0.0 Participants |
Secondary
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Occurrence of Stent Fracture at Target Lesion | 0.0 Participants |
Secondary
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 360 days or ITT subjects with follow-up of at least 330 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Occurrence of Stent Fracture at Target Lesion | 0.0 Participants |
Secondary
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Time frame: Subacute (>24 hours to 30 days)
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Stent Thrombosis | 2 Participants |
Secondary
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria. Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Stent Thrombosis | 3 Participants |
Secondary
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria. Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Stent Thrombosis | 3 Participants |
Secondary
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria. Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Stent Thrombosis | 3 Participants |
Secondary
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Time frame: Acute (0-24 hours)
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Stent Thrombosis | 0 Participants |
Secondary
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Stent Thrombosis | 3 Participants |
Secondary
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Time frame: Late (>30 days to 1 year)
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Stent Thrombosis | 1 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Failure (TLF) | 32 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.
Time frame: 30 days
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Failure (TLF) | 8 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.
Time frame: 6 months
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Failure (TLF) | 11 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Failure (TLF) | 19 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Failure (TLF) | 26 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Failure (TLF) | 29 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site.
Time frame: 30 days
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Revascularization (TLR) | 2 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Time frame: 6 months
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Revascularization (TLR) | 5 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Revascularization (TLR) | 13 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Revascularization (TLR) | 18 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Revascularization (TLR) | 19 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Lesion Revascularization (TLR) | 21 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when any of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.
Time frame: 30 days
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel Failure (TVF) | 8 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel Failure (TVF) | 36 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel Failure (TVF) | 32 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel Failure (TVF) | 29 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel Failure (TVF) | 21 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.
Time frame: 6 months
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel Failure (TVF) | 12 Participants |
Secondary
Number of Participants With Target Vessel-related MI
TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Time frame: 30 days
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel-related MI | 23 Participants |
Secondary
Number of Participants With Target Vessel-related MI
TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Time frame: 4 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel-related MI | 28 Participants |
Secondary
Number of Participants With Target Vessel-related MI
TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Time frame: 3 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel-related MI | 28 Participants |
Secondary
Number of Participants With Target Vessel-related MI
TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Time frame: 2 years
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel-related MI | 27 Participants |
Secondary
Number of Participants With Target Vessel-related MI
TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Time frame: 1 year
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel-related MI | 25 Participants |
Secondary
Number of Participants With Target Vessel-related MI
TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Time frame: 6 months
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTO Treatment | Number of Participants With Target Vessel-related MI | 24 Participants |
Secondary
Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. TIMI Classification: TIMI 0 No perfusion. TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run. TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel. TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set.The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTO Treatment | Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure | 0 | 95.9 percentage of participants |
| CTO Treatment | Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure | 1 | 3.6 percentage of participants |
| CTO Treatment | Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure | 2 | 0.0 percentage of participants |
| CTO Treatment | Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure | 3 | 0.5 percentage of participants |
Secondary
Percentage of Participants With Change in TIMI Flow Grade: Post-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. TIMI Classification: TIMI 0 No perfusion. TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run. TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel. TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTO Treatment | Percentage of Participants With Change in TIMI Flow Grade: Post-procedure | 0 | 0.5 percentage of participants |
| CTO Treatment | Percentage of Participants With Change in TIMI Flow Grade: Post-procedure | 1 | 0.0 percentage of participants |
| CTO Treatment | Percentage of Participants With Change in TIMI Flow Grade: Post-procedure | 2 | 1.8 percentage of participants |
| CTO Treatment | Percentage of Participants With Change in TIMI Flow Grade: Post-procedure | 3 | 97.7 percentage of participants |
Secondary
Percentage of Participants With Clinically Significant Perforation
Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTO Treatment | Percentage of Participants With Clinically Significant Perforation | Post Last Mini-Trek Balloon Angiography (n=67) | 0.0 percentage of participants |
| CTO Treatment | Percentage of Participants With Clinically Significant Perforation | Final Angiography (n=221) | 0 percentage of participants |
| CTO Treatment | Percentage of Participants With Clinically Significant Perforation | Site reported (n=222) | 0.0 percentage of participants |
Secondary
Percentage of Participants With Device Success
Achievement of \<50% diameter stenosis within the target lesion segment using assigned study device
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Device Success | 100 percentage of participants |
Secondary
Percentage of Participants With Procedural Success With Antegrade Crossing
Defined as device success and absence of in-hospital MACE with antegrade crossing technique.
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Procedural Success With Antegrade Crossing | 97.9 percentage of participants |
Secondary
Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART) | 100 percentage of participants |
Secondary
Percentage of Participants With Procedural Success With Kissing Wire Technique
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set.The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Procedural Success With Kissing Wire Technique | 100 percentage of participants |
Secondary
Percentage of Participants With Procedural Success With Knuckle Wire
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Procedural Success With Knuckle Wire | 100.0 percentage of participants |
Secondary
Percentage of Participants With Procedural Success With Multiple Crossing Techniques
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Procedural Success With Multiple Crossing Techniques | 80.0 percentage of participants |
Secondary
Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing | 91.7 percentage of participants |
Secondary
Percentage of Participants With Procedural Success With Reverse CART
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Procedural Success With Reverse CART | 77.8 percentage of participants |
Secondary
Percentage of Participants With Procedural Success With Sub Intimal Technique
Defined as device success and absence of in-hospital MACE with antegrade crossing technique.
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Procedural Success With Sub Intimal Technique | 100.0 percentage of participants |
Secondary
Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTO Treatment | Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique | 100 percentage of participants |
Secondary
Percentage of Participants With Procedure Success
Device success and absence of in-hospital MACE. Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves). Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment.
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTO Treatment | Percentage of Participants With Procedure Success | Per Protocol MI definition | 96.4 percentage of participants |
| CTO Treatment | Percentage of Participants With Procedure Success | Per ARC MI definition | 89.6 percentage of participants |
Secondary
Resource Utilization: Contrast Volume
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CTO Treatment | Resource Utilization: Contrast Volume | 259.00 mL | Standard Deviation 136.74 |
Secondary
Resource Utilization: Fluoroscopic Time
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CTO Treatment | Resource Utilization: Fluoroscopic Time | 33.61 Minutes | Standard Deviation 23.29 |
Secondary
Resource Utilization: Procedural Time
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Population: ITT set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CTO Treatment | Resource Utilization: Procedural Time | 79.88 Minutes | Standard Deviation 48.5 |