An observational registry study of ISAR SUMMIT coronary stent system in coronary artery diseased patients of Indian populatio
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2022/07/044472
- Lead Sponsor
- Dr Praveen Chandra
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female patient with age > 18 Years
2. Patients with coronary artery disease undergoing percutaneous coronary intervention(PCI) with ISAR Summit Polymer Free Everolimus Eluting Coronary Stent System
3. Patients or legal guardian who understands the study requirements and can provide informed consent in writing
1. Concurrent participation in another clinical trial that involves an investigational drug or device
2. Participant is pregnant or nursing an infant or child or planning to come pregnant while in the study
3. Concurrent medical condition with a life expectancy of less than 12 months
4. Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or ticagrelor, Everolimus or similar drugs,or any other analogue or derivative, cobalt, chromium or contrast media
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiac Death <br/ ><br>Target Vessel failure related Myocardial Infarction (TV- MI) <br/ ><br>Clinically driven Target Lesion Revascularization (TLR) <br/ ><br>Timepoint: 1 Year
- Secondary Outcome Measures
Name Time Method Patient oriented composite (PoCE) defined as the composite of all- cause death, <br/ ><br>any MI, any stroke and any Revascularization) <br/ ><br>Cardiac Death <br/ ><br>Target Vessel failure related Myocardial Infarction (TV- MI) <br/ ><br>Clinically driven Target Lesion Revascularization (TLR) <br/ ><br>Definite/Probable Stent Thrombosis (defined by Academic Consortium (ARC) criteria <br/ ><br> <br/ ><br>Procedural Endpoints <br/ ><br>Device success <br/ ><br>Residual coronary stenosis 50%, normal coronary flow and absence of coronary dissection <br/ ><br>Timepoint: 30 days, 180 days, and 1 year post-index procedure