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

Not Applicable

Completed

• Conditions: Atherosclerotic heart disease of native coronary artery,

• Registration Number: CTRI/2017/11/010531
• Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary

This is aretrospective, observational, real-world study to evaluate safety and performance of Drug Eluting Stent and BareMetal Stent in the treatment of approximately2000 patients with coronary artery lesions will be enrolledfrom BarodaHeart Institute (BHI) in India.

The objective of thestudy is to evaluate safety and performance of OSUMâ„¢ and Metaforâ„¢ inthe real world atdifferent time points [Time Frame: In-Hospital, 1 month, 6months, 12 months and 24 months].

All Subjects will be approached to sign ICFapproved by respective Ethics Committee before starting the study relatedprocess. A list of all the potentialpatients meeting inclusion criteria will be selected for the study.

Subject’sclinical/telephonic follow-upwill be taken at 1 month ± 07 days, 6 months ± 14 days, 12months ± 14 days and 24 months ± 28 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-17
• Study Completion: 2016-08-10
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patients who have been treated with OSUMâ„¢ and/or Metaforâ„¢.
• Patients who are contactable, willing to participate will be taken into the study by signing voluntary informed consent form.

Exclusion Criteria

There are no exclusion criteria for this study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)	In-Hospital, 1 month, 6 months, 12 months and 24 months

Secondary Outcome Measures

Name	Time	Method
1. Target vessel failure (TVF)	2. Stent Thrombosis (Definite, possible, and Probable) Rate as Defined by Academic Research Consortium (ARC)

Trial Locations

Locations (1)

Baroda Heart Institute and Research Centre; 🇮🇳 Vadodara, GUJARAT, India

Baroda Heart Institute and Research Centre

🇮🇳Vadodara, GUJARAT, India

Dr Mahesh Basarge

Principal investigator

9825026760

mahesh_basarge@yahoo.co.in