Post Marketing Survey of PRISTINE Coronary Stent
- Registration Number
- CTRI/2021/01/030701
- Lead Sponsor
- Relisys Medical Devices Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or non-pregnant female: at least 18 years of age
2.Undergone PCI for de-novo coronary lesions for stable angina / acute coronary syndrome (STEMI, N-STEMI, Unstable angina) with PRISTINE DES
3.Patient agrees to comply with specified follow-up evaluations at the site
4.Patient or LAR providing written informed consent
5.Patient is willing to come back for follow-up evaluations including OCT after 9 months – in selected patients
1. Patients presented with heart failure (Killips class 3 and 4 during hospitalization)
2. Renal failure with eGFR < 60
3. Any other chronic organ / system disease (Chronic hepatic / pulmonary etc.)
4. CVA within last 12 months
5. Chronic total occlusion, Bifurcation lesion with significant side branch, lesion in bypass graft
6. Prior stenting in the target vessel
7. Patient has a life expectancy < 12 months
8. Target vessel diameter below 2.5mm
9. Patient is a recipient of a heart transplant
10. Prior history of significant bleeding (within the previous 6 months) that might preclude use of dual antiplatelet therapy.
11. Pregnant or nursing woman or who wants to become pregnant in near future
12. Known allergies or hypersensitivity to Clopidogrel bisulfate, Cobalt Chromium alloy, Everolimus and and contrast media that cannot be medically managed.
13. Total length of overlapping stents in a single vessel more than 60mm
14. In the investigator opinion, any significant medical condition which may interfere with the patients optimal participation in this study
15. Intervention of another coronary lesion has occurred within 90 days before or is planned within 90 days after the index procedure.
16. Patient who has participated in other trial whose primary end-point is yet to be met.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major adverse cardiac event (MACE) rates, defined as cardiac death, myocardial infarction and stent thrombosis through 12-months post procedureTimepoint: 12M
- Secondary Outcome Measures
Name Time Method 1.Target Lesion Failure (TLF) at 30-days, 6-months and 12 months, defined as Cardiac death, Target Vessel Myocardial Infarction (TV-MI) and Clinically-indicated TLRTimepoint: 30 Days, 6M and 12M;All individual end-points of MACE and TLFTimepoint: 12M;Device success defined as achievement of a final residual in-stent diameter stenosis of 50% (visual estimate).Timepoint: Day 1;Procedural success defined as achievement of a final in-stent diameter stenosis of 50% (by visual estimate), without the occurrence MACE during the hospital stay (up to 7 days if a subject still in the hospital).Timepoint: 7 Days