angina coronary artery disease
Conditions
Interventions
Studystent implantation, followed by OCT during initial procedure and 6 month
follow-up angio with OCT.
Sponsors
Svelte Medical Systems, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patient >18 years old. - Eligible for percutaneous coronary intervention (PCI). - Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure. - Patient is willing to comply with specified follow-up evaluation. - Acceptable candidate for coronary artery bypass graft (CABG) surgery. - (un)stable angina pectoris or a positive functional ischemia study. - Male or non-pregnant female patient of non child-bearing potential. - A number of specific Angiographic Inclusion Criteria (see protocol).
Exclusion criteria
Exclusion criteria: - Currently enrolled in another trial that has not completed the primary endpoint. - A previous coronary interventional procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (MACE): defined as cardiac death, MI [Q or Non Q-wave], emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q or Non Q-wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods at 6 months 2. Angiographic Restenosis rate at 6 months (for 50 patients) 3. Composite endpoint of cardiac death and MI at 30 days and 6 months post procedure 4. TLR at 30 and 180 days 5. Rates for each component of the MACE composite endpoint (cardiac death, MI, emergent coronary artery bypass graft (CABG)), and TLR at 30 days and 6 months post-procedure 6. Rates for each component of target vessel failure (TVF) composite endpoint (cardiac death, target vessel MI, TVR) reported at 30 days and 6 months post-procedure 7. Acute success rates: a. Device Success: Attainment of | — |
Countries
Netherlands
Outcome results
None listed