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To evaluate safety and performance of Drug Eluting Stent and Bare Metal Stent in the treatment of patients with coronary artery blockage.

A retrospective, observational, real-world, safety and performance evaluation of DES and BMS for coronary artery lesions.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/11/010531
Enrollment
2000
Registered
2017-11-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: OSUMâ?¢ and Metaforâ?¢: OSUMâ?¢ -Cobalt Chromium Coronary Stent System Metaforâ?¢ Sirolimus-Eluting Coronary Stent System Control Intervention1: NIL: NIL

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who have been treated with OSUM• and/or Metafor•. 2. Patients who are contactable, willing to participate will be taken into the study by signing voluntary informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are no exclusion criteria for this study.

Design outcomes

Primary

MeasureTime frame
Major Adverse Cardiac Events (MACE)Timepoint: In-Hospital, 1 month, 6 months, 12 months and 24 months

Secondary

MeasureTime frame
1. Target vessel failure (TVF) 2. Stent Thrombosis (Definite, possible, and Probable) Rate as Defined by Academic Research Consortium (ARC)Timepoint: 1. 1 month, 6 months, 12 months and 24 months 2. In-Hospital, 1 month, 6 months, 12 months and 24 months

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Meril Life Sciences Pvt Ltd

ashok.thakkar@merillife.com9879443584

Outcome results

None listed

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