Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: BioMimeâ?¢ Morph Sirolimus Eluting Coronary Stent System: Sirolimus Eluting Coronary Stent System
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Event, Freedom of target lesion failure (TLF), Target vessel failure (TVF), Timepoint: 1 month (±14days), 6 months (± 28 days), 12 months (± 28 days) and 24 months (± 28 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedural success, Device successTimepoint: Within 24 hours | — |
Countries
India
Contacts
Public ContactDr Suresh V Patted
KLES Heart Foundation
Outcome results
None listed