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.

A prospective, single-arm, multi-centre study to evaluate the safety and performance of MeRes100™ Sirolimus Eluting BioResorbable Vascular Scaffold System by clinical and imaging outcomes in patients with coronary artery disease - RESET

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/02/062438

Enrollment

200

Registered

2024-02-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: MeRes100™ Sirolimus Eluting BioResorbable Vascular Scaffold System: This is a prospective study aims to assess the safety and effectiveness of the MeRes100™ Sirolimus Eluting BioResorba

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Target Lesion Failure (TLF)Timepoint: 12 months	—

Secondary

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

Countries

India

Contacts

Public ContactDr Deepak Davidson

Caritas Hospital and Institute of Health Sciences

deepakdavidson@yahoo.com9447216959

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026