Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia
Conditions
Keywords
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
Brief summary
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention. Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring PTCA catheter during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.
Interventions
DEVICEScoreflex NC Scoring PTCA catheter
To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Sponsors
ClinLogix. LLC
OrbusNeich
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
Clinical Inclusion Criteria 1. Subject is ≥ 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures. 3. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study. 4. Subjects must have a single or double vessel coronary artery disease (CAD) and clinical evidence of ischemic heart disease, such as CAD, stable / unstable angina or silent ischemia. Angiographic Inclusion Criteria 5. Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention. 6. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries. 7. Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation. 8. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO). 9. The non-target lesion must be located in different coronary artery from the Target lesion. 10. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. Clinical
Exclusion criteria
1. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated. 2. Subject with known diagnosis of STEMI or NSTEMI at index presentation or within 7 days of study screening. 3. Subject with known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days before index procedure. 4. Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure. 5. A serum creatinine level \> 2.0 mg/dl within 7 days prior to index procedure. 6. Cerebrovascular accident (CVA) within the past 6 months. 7. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months. 8. Subject has a known left ventricular ejection fraction (LVEF) \<30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary) 9. Target lesion located within an arterial or saphenous vein graft or graft anastomosis Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device Procedural Success | Peri-procedural (at Day 0) | Device procedural success consisting of the following: * Successful delivery, inflation, deflation, and withdrawal of the study balloon * No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon * Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | Endpoints will be measured through hospital discharge (expected to be within 24 hours) | In-hospital Major Adverse Cardiac Events (MACE), a composite of: * All death (cardiac and non-cardiac) * Myocardial infarction (MI) * Target Lesion Revascularization (TLR), clinically indicated |
| Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel | Endpoint will be measured through hospital discharge (expected to be within 24 hours) | In-hospital stent thrombosis (ST) within the Target Vessel |
| Number of Participants With Angiographic Procedural Success | Peri-procedural (at Day 0) | Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting |
| Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture | Peri-procedural | Occurrence of Scoreflex NC Study Balloon rupture |
| Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA)) | Peri-procedural | Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA). Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline. |
| Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) | Endpoint will be measured through hospital discharge (expected to be within 24 hours) | Clinically Significant Arrhythmias (Requiring Intervention) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Scoreflex NC Scoring PTCA Catheter Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters | 200 |
| Scoreflex NC Scoring PTCA Catheter Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters | 221 |
| Total | 421 |
Baseline characteristics
| Characteristic | Scoreflex NC Scoring PTCA Catheter |
|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 8.98 |
| Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed) 0,0,0 | 2 Lesions |
| Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed) 0,0,1 | 3 Lesions |
| Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed) 0,1,0 | 38 Lesions |
| Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed) 0,1,1 | 8 Lesions |
| Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed) 1,0,0 | 16 Lesions |
| Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed) 1,0,1 | 3 Lesions |
| Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed) 1,1,0 | 8 Lesions |
| Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed) 1,1,1 | 6 Lesions |
| Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed) Non-bifurcation lesions | 137 Lesions |
| Angiographic Characteristics: Lesion Characteristics (Core Lab assessed) Lesion Length | 18.37 Millimeters STANDARD_DEVIATION 12.93 |
| Angiographic Characteristics: Lesion Characteristics (Core Lab assessed) Minimal Luminal Diameter | 0.8 Millimeters STANDARD_DEVIATION 0.4 |
| Angiographic Characteristics: Lesion Characteristics (Core Lab assessed) Moderate/Severe Calcification | 81 Lesions |
| Angiographic Characteristics: Lesion Characteristics (Core Lab assessed) Moderate/Severe Tortuosity | 7 Lesions |
| Angiographic Characteristics: Lesion Characteristics (Core Lab assessed) Total Occlusion | 11 Lesions |
| Angiographic Characteristics: Lesion Location (Core Lab assessed) Distal | 23 Lesions |
| Angiographic Characteristics: Lesion Location (Core Lab assessed) Middle | 93 Lesions |
| Angiographic Characteristics: Lesion Location (Core Lab assessed) Ostial | 7 Lesions |
| Angiographic Characteristics: Lesion Location (Core Lab assessed) Proximal | 98 Lesions |
| Angiographic Characteristics: Vessel Location (Core Lab assessed) Left Anterior Descending Artery (LAD) | 97 Lesions |
| Angiographic Characteristics: Vessel Location (Core Lab assessed) Left Circumflex Artery (LCX) | 55 Lesions |
| Angiographic Characteristics: Vessel Location (Core Lab assessed) Not Identified | 1 Lesions |
| Angiographic Characteristics: Vessel Location (Core Lab assessed) Right Coronary Artery (RCA) | 68 Lesions |
| Baseline Thrombolysis in Myocardial Infarction (TIMI) Flow (Core Lab assessed) 0 (no perfusion) | 6 Lesions |
| Baseline Thrombolysis in Myocardial Infarction (TIMI) Flow (Core Lab assessed) 1 (penetration with minimal perfusion) | 5 Lesions |
| Baseline Thrombolysis in Myocardial Infarction (TIMI) Flow (Core Lab assessed) 2 (partial perfusion) | 6 Lesions |
| Baseline Thrombolysis in Myocardial Infarction (TIMI) Flow (Core Lab assessed) 3 (complete perfusion) | 204 Lesions |
| Cardiac History Prior Coronary Artery Bypass Graft | 26 Participants |
| Cardiac History Prior Myocardial Infarction | 61 Participants |
| Cardiac History Prior Percutaneous Coronary Intervention | 106 Participants |
| Cardiac Risk Factors Cigarette Smoking (within 30 days) | 37 Participants |
| Cardiac Risk Factors Diabetes Mellitus | 88 Participants |
| Cardiac Risk Factors Diabetes Mellitus (Insulin requiring) | 20 Participants |
| Cardiac Risk Factors Hypercholesterolemia Requiring Treatment | 181 Participants |
| Cardiac Risk Factors Hypertension Requiring Treatment | 182 Participants |
| Current Cardiac Status Asymptomatic | 18 Participants |
| Current Cardiac Status Silent Ischemia | 8 Participants |
| Current Cardiac Status Stable Angina | 116 Participants |
| Current Cardiac Status ST-Elevation Myocardial Infarction (STEMI) | 1 Participants |
| Current Cardiac Status Unstable Angina | 57 Participants |
| Race/Ethnicity, Customized Race American Indian/Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Black | 18 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian/Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 178 Participants |
| Region of Enrollment United States | 200 Participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 200 |
| other Total, other adverse events | 8 / 200 |
| serious Total, serious adverse events | 1 / 200 |
Outcome results
Primary
Number of Participants With Device Procedural Success
Device procedural success consisting of the following: * Successful delivery, inflation, deflation, and withdrawal of the study balloon * No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon * Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure
Time frame: Peri-procedural (at Day 0)
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scoreflex NC Scoring PTCA Catheter | Number of Participants With Device Procedural Success | 187 Participants |
Secondary
Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA))
Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA). Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.
Time frame: Peri-procedural
Population: Analysis population consists of intent-to-treat subject population. Please note that the data for Number of Participants that had Improvement in Minimum Lumen Diameter was not analyzable in 23 patients by the Angiographic Core Lab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scoreflex NC Scoring PTCA Catheter | Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA)) | 161 Participants |
Secondary
Number of Participants With Angiographic Procedural Success
Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting
Time frame: Peri-procedural (at Day 0)
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scoreflex NC Scoring PTCA Catheter | Number of Participants With Angiographic Procedural Success | 197 Participants |
Secondary
Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)
Clinically Significant Arrhythmias (Requiring Intervention)
Time frame: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scoreflex NC Scoring PTCA Catheter | Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) | 1 Participants |
Secondary
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
In-hospital Major Adverse Cardiac Events (MACE), a composite of: * All death (cardiac and non-cardiac) * Myocardial infarction (MI) * Target Lesion Revascularization (TLR), clinically indicated
Time frame: Endpoints will be measured through hospital discharge (expected to be within 24 hours)
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scoreflex NC Scoring PTCA Catheter | Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | 9 Participants |
Secondary
Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel
In-hospital stent thrombosis (ST) within the Target Vessel
Time frame: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scoreflex NC Scoring PTCA Catheter | Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel | 0 Participants |
Secondary
Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture
Occurrence of Scoreflex NC Study Balloon rupture
Time frame: Peri-procedural
Population: Analysis population consists of intent-to-treat subject population. Site reported data represented on the use of 239 Scoreflex NC Scoring PTCA catheter study devices.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Scoreflex NC Scoring PTCA Catheter | Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture | 2 Scoreflex NC Scoring PTCA catheters |