Health Condition 1: I248- Other forms of acute ischemic heart disease Health Condition 2: I258- Other forms of chronic ischemic heart disease
Conditions
Interventions
Intervention1: VIVO ISAR: Polymer Free Sirolimus Eluting Coronary Stent System will be
deplyod on procedure
day and safety data will be collected through discharge, at 1 month, 6 month , 1,2 and 3 yea
Sponsors
Translumina Therapeutics LLP
Eligibility
Inclusion criteria
Inclusion 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 VIVO-ISAR (one or multiple stents). 6. In case of multiple vessel disease all vessels must be treated with VIVO-ISAR 7. No limitation on the number of treated lesions, vessels, and lesion length.
Exclusion criteria
Exclusion criteria: 1. Patients treated with stent other than study device 2. Patients have other planned coronary vascular treatments after index procedure in same sitting. 3. Patients 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, sirolimus or similar drugs, or any other analogue or derivative, probucol, cobalt, chromium or contrast media 8. Prior stenting in target or non-target vessel within 90 days before index procedure 9. Patient participating in other study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device Oriented Composite endpoints post index procedure: â?¢ Cardiac Death â?¢ Target Vessel related Myocardial Infarction (TV-MI) and â?¢ Clinically driven Target Lesion Revascularization (TLR) Timepoint: Clinical endpoints measured at 1 month, 6 months, 1 year, 2 years and 3 years post index procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, any stroke and any revascularization â?¢ Definite/Probable Stent thrombosis as per Academic Research Consortium [ARC] definitions â?¢ Device success ï?? 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. â?¢ Procedural success ï?? Defined as attainment of device success without the occurrence of ischemia-driven major adverse cardiac event peri-procedural, post-procedural and within discharge. â?¢ In case of multiple lesions treatment, all treated lesions must meet the clinical procedural success Timepoint: Clinical endpoints measured at 1 month, 6 months, 1 year, 2 years and 3 years post index procedure. | — |
Countries
India
Contacts
Public ContactDr Neeraj Kumar
Translumina Therapeutics LLP
Outcome results
None listed