Health Condition 1: I708- Atherosclerosis of other arteries
Conditions
Interventions
Intervention1: VIVO-ISAR: Polymer free sirolimus eluting coronary stent will be used during index procedure only.
Patient will be followed up till one year post procedure.
Control Intervention1: NIl:
Sponsors
Translumina Therapeutics LLP
Eligibility
Inclusion criteria
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 â?¤ 3 months DAPT after PCI as per standard of care.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ischemic endpoint: cardiovascular death myocardial infarction (not clearly attributable to a non target vessel) definite probable stent thrombosis or urgent target lesion revascularisation Bleeding endpoint: bleeding defined as Bleeding Academic Research Consortium (BARC) class 3 or higherTimepoint: 30 days, 3 months, and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality Cardiovascular death Myocardial infarction Stroke Stent thrombosis definite probable Target vessel revascularisation TVR Ischemia driven target lesion revascularisation TLR Urgent TLR BARC class 2 BleedingTimepoint: 30 days 3 months 1 year | — |
Countries
India
Contacts
Public ContactMr Diptendu Chatterjee
Translumina Therapeutics LLP
Outcome results
None listed