Study of VIVO ISAR stent in patients undergoing percutaneous coronary intervention with short dual-anti-platelet therapy
Phase 4
- Conditions
- Health Condition 1: I708- Atherosclerosis of other arteries
- Registration Number
- CTRI/2024/01/061159
- Lead Sponsor
- Translumina Therapeutics LLP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Ability to provide written informed consent.
Treated only with the VIVO ISAR stent system.
More than 18 years old.
Male or non-pregnant female patient.
Intended for treatment with = 3 months DAPT after PCI as per standard of care.
Exclusion Criteria
Cardiogenic shock hemodynamic instability around the time of the index procedure.
Concurrent medical condition with a life expectancy of less than 12
months.
Allergy or contraindication to antiplatelet therapy cobalt chromium
sirolimus or any known hypersensitivity to the planned anti-platelet drugs.
History of cerebrovascular accident in the last 6 months.
Pregnant female.
PCI performed within the previous 3 months from the date of index procedure.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ischemic endpoint: cardiovascular death myocardial infarction (not <br/ ><br>clearly attributable to a non target vessel) definite probable stent thrombosis <br/ ><br>or urgent target lesion revascularisation <br/ ><br>Bleeding endpoint: bleeding defined as Bleeding Academic Research <br/ ><br>Consortium (BARC) class 3 or higherTimepoint: 30 days, 3 <br/ ><br>months, and 12 months
- Secondary Outcome Measures
Name Time Method All-cause mortality <br/ ><br>Cardiovascular death <br/ ><br>Myocardial infarction <br/ ><br>Stroke <br/ ><br>Stent thrombosis definite probable <br/ ><br>Target vessel revascularisation TVR <br/ ><br>Ischemia driven target lesion revascularisation TLR <br/ ><br>Urgent TLR <br/ ><br>BARC class 2 BleedingTimepoint: 30 days <br/ ><br>3 months <br/ ><br>1 year