To evaluate safety and performance of the BioMimeâ?¢ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2017/03/008167
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 257
1.The patient must be at least 18 years of age. 2.Significant native coronary artery stenosis (more than 50% by visual estimate) with lesion length of less and equal to 56 mm.
3.The patient or guardian agrees to the protocol requirements and the schedule of follow-up and provides informed written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
1. Patients who are actively participating in another drug or device investigational study.
2.Patients who are unwilling to participate in the study.
3.Patients contraindicated to any of the following medications aspirin, heparin, clopidogrel, cobalt chromium contrast agents and sirolimus.
4.Female patient with known pregnancy or who are lactating.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Event, <br/ ><br>Freedom of target lesion failure (TLF), <br/ ><br>Target vessel failure (TVF), <br/ ><br>Timepoint: 1 month (±14days), 6 months (± 28 days), 12 months (± 28 days) and 24 months (± 28 days)
- Secondary Outcome Measures
Name Time Method Procedural success, <br/ ><br>Device successTimepoint: Within 24 hours