A study to collect and analyse safety and performance data of Sirolimus Eluting Cobalt Chromium Coronary Stent in Indian CAD patients.
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2022/09/045283
- Lead Sponsor
- Translumina Therapeutics LLP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Real world, all comers ? Indian patients meeting all the below mentioned criteria:
1. Age > 18 years
2. Patients who can provide informed consent form in writing to provide data for the study.
3. Patients who allow their data to be collected for the study at predefined follow-up periods.
4. Patients that need a treatment with drug eluting stent.
5. Presence of one or more coronary artery stenosis in a native coronary artery or a saphenous vein graft from 2.0 to 4.0 mm in diameter planned for PCI with Study device-Sirolimus Eluting Coronary Stent System (CoCr) (one or multiple stents).
6. In case of multiple vessel disease all vessels must be treated with Study device-Sirolimus Eluting Coronary Stent System (CoCr) only
7. No limitation on the number of treated lesions, vessels, and lesion length.
Patients meeting below points will be excluded from the study
1. The Patients treated with stent other than Study device-Sirolimus Eluting Coronary Stent System (CoCr)
2. Patients have other planned coronary vascular treatments after index procedure in same sitting.
3. Patient unwilling or unable to comply with the postoperative visits necessary for data collection.
4. Patient is pregnant or nursing an infant or child or planning to become pregnant while in the study.
5. Concurrent medical condition with a life expectancy of less than 3 years
6. Patient is a recipient of heart transplant
7. Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or ticagrelor or similar drugs, or any other analogue or derivative, cobalt, chromium or contrast media
8. Prior stenting in target or non-target vessel within 90 days of index procedure
9.Patient participating in other study
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Device Oriented Composite endpoints will be captured for below parameters post index procedure: Cardiac Death, <br/ ><br>Target Vessel related Myocardial Infarction (TV-MI) and <br/ ><br>Clinically driven Target Lesion Revascularization (TLR) <br/ ><br>Timepoint: Three year Followup
- Secondary Outcome Measures
Name Time Method Clinical endpoints measured for: <br/ ><br>1. Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, any stroke and any revascularization <br/ ><br>2. Definite/Probable Stent thrombosis as per Academic Research Consortium [ARC] definitions <br/ ><br>3. Device success (Defined as successful delivery and deployment of the stent(s) at the intended target lesion (including successful delivery and deployment of multiple overlapping stents) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% of the target lesion as observed by angiography or by visual estimation at index procedure). <br/ ><br>4. Procedural success (Defined as attainment of device success without the occurrence of ischemia-driven major adverse cardiac event peri-procedural, post-procedural and within discharge) <br/ ><br>Timepoint: Clinical endpoints measured at 1 month, 6 months, 1 year, 2 years and 3 years post index procedure