de Novo Stenotic Lesions in Native Coronary Arteries
Conditions
Brief summary
This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
Detailed description
The main objective of this study is to collect and analyze additional information about the safety and effectiveness of the NIRxcell Stent System in the treatment of de novo stenotic lesions in native coronary arteries in the US population. The primary endpoint will be the rate of target vessel failure (TVF) at 3 years of treatment with the NIRxcell Stent System. This rate will be compared with a performance goal derived from a meta-analysis of coronary stenting with bare metal stents (BMS).
Interventions
DEVICEStenting procedure
All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
Sponsors
Medinol Ltd.
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 1. Subject is ≥18 years old. 2. Subject is eligible for percutaneous coronary intervention (PCI). 3. Subject is eligible for dual anti-platelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel or ticagrelor for a minimum of 1 month. 4. Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure. 5. Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone. 6. Subject is an acceptable candidate for coronary artery bypass graft (CABG) surgery. 7. Subject has stable angina pectoris (Canadian Cardiovascular Society Classification \[CCSC\] 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g. exercise tolerance test \[ETT\], single-photon emission computerized tomography \[SPECT\], stress echocardiography or cardiac computerized tomography \[CT\]). 8. Female subjects of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment in the study. Angiographic Inclusion Criteria 1. Subject is indicated for elective stenting of a single stenotic lesion in a native coronary artery. 2. Reference vessel ≥2.5 mm and ≤4.0 mm in diameter by visual estimate. 3. Target lesion ≤30 mm in length by visual estimate (the intention should be to cover the whole lesion with 1 stent of adequate length). 4. Target lesion stenosis ≥50% and \<100% by visual estimate.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure | 3 years | The primary endpoint in this study was TVF (Target Vessel Failure) defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 3 years post-procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
Stenting procedure: All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted. | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 68.06 years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment United States | 65 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 58 / 65 |
| serious Total, serious adverse events | 40 / 65 |
Outcome results
Primary
Target Vessel Failure
The primary endpoint in this study was TVF (Target Vessel Failure) defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 3 years post-procedure.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Target Vessel Failure | 15 percentage of TVF |