The aim is to evaluate the safety and efficacy of MeRes100™ Sirolimus Eluting BioResorbable Vascular Scaffold in coronary artery disease patients.It enhances coronary luminal diameter in symptomatic ischemic heart disease, addressing de novo lesions in native coronary arteries.

Phase 4

Conditions: Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Registration Number: CTRI/2024/02/062438

Lead Sponsor: Meril Diagnostics Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients aged =18 years.

2. Patients with de novo coronary artery lesions with reference vessel diameter of =2.75 mm to =4.0 mm.

3. Patient has given written informed consent for participation prior to enrolment.

4. Patient is willing to undergo all study procedures and follow-up requirements.

Exclusion Criteria

1. Hypersensitivity or allergy to aspirin, heparin, clopidogrel, bivalirudin,ticlopidine, prasugrel, ticagrelor and drug such as Sirolimuds or similar drugs or any analogue or derivative, poly-Llactide, poly-DL-lactide, platinum, or with any contrast media Patient in whom anti-platelet and/or anti-coagulant therapy are contraindicated

2. Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon

3. Pregnant or lactating female

4. Left main coronary artery disease

5. Aorta ostial lesion and Lesion in a bypass graft

6. Any PCI less than 6 months prior to the index procedure

7. Previous CABG in the target vessel

8. And other exclusions as specified in the protocol

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)Timepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death <br/ ><br>Target Vessel Myocardial Infarction <br/ ><br>Clinically-Driven TLR, Target Vessel Failure (TVF) <br/ ><br>Target Vessel Revascularization (TVR) <br/ ><br>Scaffold thrombosis <br/ ><br>Quality of Life (QoL) <br/ ><br>Procedure success <br/ ><br>Device success <br/ ><br>Length of hospital stayTimepoint: Baseline, Discharge, 1 month, 6 months,12 months, 24 months & 36 months