The main objective of this study is to evaluate the safety and effectiveness of the COBRA PzF™ Coronary Stent System in the treatment of de novo lesions in native coronary arteries. The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the COBRA PzFTM Coronary Stent System. This rate will be compared to a performance goal derived using a meta-analysis from published historical data of the standard-of-care therapy, coronary stenting with bare metal stents.
PRIMARY STUDY HYPOTHESIS The CeloNova COBRA PzFTM Study will have a primary endpoint (TVF) rate less than 19.62% and by that will meet the performance goal for bare metal stents, per the results of the historical control group combined with relevant data for EXPRESS™, Driver™, Presillion/Presillion plus™ and NIRFLEX™ stents.
SECONDARY STUDY HYPOTHESIS The powered secondary endpoint for this trial is that the CeloNova COBRA PzFTM Study will have a 9-month in-stent late loss (LL) that meets or is lower than the performance goal of 1.1 mm.
NUMBER OF PATIENTS 296 patients will be enrolled to account for loss to follow-up, which is estimated to be approximately 5% (resulting in 281 evaluable patients), at up to 40 sites in United States and OUS. At least 40% of subjects will be enrolled in the United States.
PRIMARY ENDPOINT Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) \[Q wave or non-Q wave, ARC-definition\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.
SECONDARY ENDPOINTS
1. All Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
2. Cardiac Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
3. Major Adverse Cardiac Events (MACE), defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
4. MI at 30, 180 and 270, 360, 720, 1080, 1440, and 1800 days CeloNova Biosciences, Inc. Confidential CeloNova COBRA PzF™ Study Protocol # COBRA 2012-01 6 07 May 14
5. Clinically driven TLR at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
6. Stroke (ischemic and hemorrhagic) at 30, 180, 270 and 360 days
7. Clinically driven TVR at 30, 180, 270 and 360 days
8. Composite Endpoint of Cardiac Death and MI at 30, 180, 270, and 360 days
9. TVF at 30, 180, and 360 days
10. Acute Success Rates
1. Device Success: Attainment of \< 30% final residual stenosis of the target lesion using only the COBRA PzFTM Coronary Stent System.
2. Lesion Success: Attainment of \< 30% final residual stenosis of the target lesion using any percutaneous method.
3. Procedure Success: Attainment of \< 30% final residual stenosis of the target lesion and no in-hospital MACE.
11. Bleeding or Vascular Complications at hospital discharge
12. Early Stent Thrombosis (ARC defined) at 30 days
13. Late Stent Thrombosis at 180, 270, and 360 days
14. Angiographic Endpoints (on first 90 evaluable patients) at 270 days (after clinical assessment)
1. In-stent late loss (Secondary Endpoint hypothesis)
2. In-segment percent diameter stenosis (%DS) (within the 5 mm margins proximal and distal to stent)
3. In-stent percent diameter stenosis (%DS)
4. In-segment late loss
5. In-segment binary restenosis (stenosis of \> 50% of the reference vessel diameter)
6. In-stent binary restenosis
7. In-stent minimum lumen diameter (MLD)
8. In-segment MLD
9. Longitudinal stent deformation
10. Stent fracture
15. Optical Coherence Tomography Endpoints (on 45 subjects) at 270 days (after clinical assessment)
1. in-stent neointimal thickness (NT)
2. Lumen area
3. Lumen volume
4. Stent area
5. Stent volume
6. Proportion of uncovered and/or malopposed struts
7. Stent fracture
