Chronic Coronary Total Occlusion, Coronary Artery Stenosis, Coronary Bypass Graft Stenosis, Ischemic Heart Disease
Conditions
Keywords
Coronary Dilatation Catheter, Balloon Dilatation Catheter, Angioplasty, Myocardial Ischemia, Coronary Stenosis, Percutaneous Coronary Intervention (PCI), Percutaneous Transluminal Coronary Angioplasty (PTCA), Chronic Total Occlusion (CTO)
Brief summary
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.
Interventions
DEVICEMINI TREK RX 1.20 mm Coronary Dilatation Catheter
Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Subject must be at least 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure. 3. Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. 4. Subject must have single or multiple vessel coronary artery disease with clinical evidence of myocardial ischemia (e.g., stable or unstable angina or silent ischemia documented by a positive functional study). 5. Subject must be an acceptable candidate for CABG. 6. Subject must agree to undergo all protocol-required follow-up procedures. 7. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure. Angiographic Inclusion Criteria All angiographic inclusion criteria are based on visual estimation. 1. De novo or restenotic lesions in native coronary arteries or bypass grafts. 2. A maximum of two lesions, including at least one target lesion, in up to two major epicardial distribution trees. Tandem lesions, defined as multiple, focal lesions that can be covered by one stent, will be considered as a single lesion. 3. If one target lesion and one non-target lesion are to be treated, the target and non-target lesions must be located in different major epicardial distribution trees. 4. The target lesion must have a diameter stenosis of ≥ 70% by visual estimation or online quantitative coronary angiography (QCA), which may include chronic total occlusion (CTO). 5. Lesions may be located in highly tortuous vessels.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Procedure Success | On Day 0 (From the start to end of the interventional procedure) | Procedure success was defined as meeting all the following after single or multiple attempts: 1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion, 2. Successful inflation and deflation with the MINI TREK RX 1.20 mm balloon, 3. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon, and 4. Achieve a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Lesion Success | On Day 0 (From the start to end of the interventional procedure) | Lesion Success was defined as meeting all the following after single or multiple attempts: 1. Successful dilatation with any device(s), defined as achieving a final residual percent diameter stenosis of \< 50%, 2. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with any device(s), and 3. Achievement of a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion. |
| Rate of Individual Procedural Parameters | On Day 0 (From the start to end of the interventional procedure) | The following parameters were assessed by either an angiographic core laboratory or the investigator at the site * Vessel perforation * Flow-limiting vessel dissection * Development of thrombus in the target vessel * Balloon rupture * Clinically significant arrhythmias requiring medical treatment or device intervention |
| Rate of Device Success | On Day 0 (From the start to end of the interventional procedure) | Device Success was defined as meeting all the following after single or multiple attempts: 1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion, defined as achieving a final residual percent diameter stenosis of \< 50%, 2. Successful dilatation with the MINI TREK RX 1.20 mm balloon as defined by improvement in Minimal Lumen Diameter (MLD) based on core lab analysis, and 3. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias that required medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon. |
| Rate of Target Lesion Failure (TLF) | In-Hospital (1 - 3 Days) | In-hospital TLF was defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the hospitalization for the index procedure |
| Rate of Stent Thrombosis | In-Hospital (1 - 3 Days) | Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Angiographic confirmation involves presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest; New ischemic ECG changes that suggest acute ischemia; Typical rise and fall in cardiac biomarkers; Non-occlusive; Occlusive thrombus Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy is a pathological confirmation. Probable stent thrombosis is considered to have occur after intracoronary stenting in case of any unexplained death within the first 30 days or any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause |
| Rate of Major Adverse Cardiac Event (MACE) | In-Hospital (1 - 3 Days) | In-hospital MACE was defined as the composite of all deaths, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR) by coronary artery bypass graft surgery (CABG) or PCI during the hospitalization for the index procedure |
Countries
United States
Participant flow
Recruitment details
A total of 71 subjects were enrolled at 4 clinical sites in the US between August 12, 2010 and December 30, 2010. All subjects were followed in-hospital up to discharge.
Participants by arm
| Arm | Count |
|---|---|
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter Patients requiring initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis will be included.
MINI TREK RX 1.20 mm Coronary Dilatation Catheter: Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions | 71 |
| Total | 71 |
Baseline characteristics
| Characteristic | MINI TREK RX 1.20 mm Coronary Dilatation Catheter |
|---|---|
| Age, Continuous | 64.75 years STANDARD_DEVIATION 10.95 |
| Prior coronary intervention | 52 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African Heritage | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islanders | 0 Participants |
| Race/Ethnicity, Customized White | 68 Participants |
| Region of Enrollment United States | 71 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 71 |
| other Total, other adverse events | 0 / 71 |
| serious Total, serious adverse events | 6 / 71 |
Outcome results
Primary
Percentage of Participants With Procedure Success
Procedure success was defined as meeting all the following after single or multiple attempts: 1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion, 2. Successful inflation and deflation with the MINI TREK RX 1.20 mm balloon, 3. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon, and 4. Achieve a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.
Time frame: On Day 0 (From the start to end of the interventional procedure)
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Percentage of Participants With Procedure Success | 98.5 percentage of participants |
Secondary
Rate of Device Success
Device Success was defined as meeting all the following after single or multiple attempts: 1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion, defined as achieving a final residual percent diameter stenosis of \< 50%, 2. Successful dilatation with the MINI TREK RX 1.20 mm balloon as defined by improvement in Minimal Lumen Diameter (MLD) based on core lab analysis, and 3. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias that required medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon.
Time frame: On Day 0 (From the start to end of the interventional procedure)
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Device Success | 96.2 Percentage of target lesions |
Secondary
Rate of Individual Procedural Parameters
The following parameters were assessed by either an angiographic core laboratory or the investigator at the site * Vessel perforation * Flow-limiting vessel dissection * Development of thrombus in the target vessel * Balloon rupture * Clinically significant arrhythmias requiring medical treatment or device intervention
Time frame: On Day 0 (From the start to end of the interventional procedure)
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Individual Procedural Parameters | Balloon Rupture | 0.0 percentage of participants |
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Individual Procedural Parameters | Development of Thrombus in the Target Vessel | 0.0 percentage of participants |
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Individual Procedural Parameters | Vessel Perforation | 0.0 percentage of participants |
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Individual Procedural Parameters | Flow-Limiting Vessel Dissection | 0.0 percentage of participants |
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Individual Procedural Parameters | Clinically Significant Arrhythmias Requiring Medical Treatment or Device Intervention | 0.0 percentage of participants |
Secondary
Rate of Lesion Success
Lesion Success was defined as meeting all the following after single or multiple attempts: 1. Successful dilatation with any device(s), defined as achieving a final residual percent diameter stenosis of \< 50%, 2. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with any device(s), and 3. Achievement of a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.
Time frame: On Day 0 (From the start to end of the interventional procedure)
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Lesion Success | 97.6 Percentage of target lesions |
Secondary
Rate of Major Adverse Cardiac Event (MACE)
In-hospital MACE was defined as the composite of all deaths, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR) by coronary artery bypass graft surgery (CABG) or PCI during the hospitalization for the index procedure
Time frame: In-Hospital (1 - 3 Days)
Population: The number of participants analyzed includes subjects who were available at that timeof analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Major Adverse Cardiac Event (MACE) | 6 Participants |
Secondary
Rate of Stent Thrombosis
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Angiographic confirmation involves presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest; New ischemic ECG changes that suggest acute ischemia; Typical rise and fall in cardiac biomarkers; Non-occlusive; Occlusive thrombus Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy is a pathological confirmation. Probable stent thrombosis is considered to have occur after intracoronary stenting in case of any unexplained death within the first 30 days or any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time frame: In-Hospital (1 - 3 Days)
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Stent Thrombosis | Acute Stent Thrombosis | 0 percentage of participants |
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Stent Thrombosis | Subacute Stent Thrombosis | 0 percentage of participants |
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Stent Thrombosis | Acute/Subacute Stent Thrombosis | 0 percentage of participants |
Secondary
Rate of Target Lesion Failure (TLF)
In-hospital TLF was defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the hospitalization for the index procedure
Time frame: In-Hospital (1 - 3 Days)
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Rate of Target Lesion Failure (TLF) | 6 Participants |