A clinical study to collect clinical safety data of Polymer Free Sirolimus Eluting Coronary Stent System from Real World Indian population.

Phase 4

Conditions: Health Condition 1: I248- Other forms of acute ischemic heart diseaseHealth Condition 2: I258- Other forms of chronic ischemic heart disease

Registration Number: CTRI/2022/11/047152

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

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

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

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Oriented Composite endpoints post index procedure: <br/ ><br>â?¢ Cardiac Death <br/ ><br>â?¢ Target Vessel related Myocardial Infarction (TV-MI) and <br/ ><br>â?¢ Clinically driven Target Lesion Revascularization (TLR) <br/ ><br>Timepoint: Clinical endpoints measured at 1 month, 6 months, 1 year, 2 years and 3 years post index <br/ ><br>procedure

Secondary Outcome Measures