To evaluate safety and performance of the BioMimeâ„¢ Morph Sirolimus-Eluting Coronary Stent Systems in the treatment of patients with coronary artery blockage.

Not Applicable

Completed

• Conditions: Atherosclerotic heart disease of native coronary artery,

• Registration Number: CTRI/2018/01/011230
• Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary

This is a   retrospective, multicenter, observational, real-world, study to evaluate safety and performance of BioMimeâ„¢ MorphSirolimus Eluting Coronary Stent Systemsin the treatment ofapproximately 400 patients with coronary artery lesions at approximately5-10 centers.

The objective of the study is to evaluate safety and performanceof BioMime in the real world settings at specific time point [Time frame: 2years follow up].

All Subjects will be approached to sign ICF approved by respectiveethics committee before starting the study related process. A list of allthe potential patients that have been treated with Sirolimus Eluting CoronaryStent Systems will be selected for the study.

As this is a retrospective study, the patients will be followed up foronly observation and the data will be collected.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-13
• Study Completion: 2017-10-11
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients who have been treated with BioMimeâ„¢ Morph.
• 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)	2 years follow up

Secondary Outcome Measures

Name	Time	Method
Target vessel failure (TVF), Stent Thrombosis, Procedure Success, Device Success	2 years follow up

Trial Locations

Locations (3)

Fortis Escorts Heart Centre; 🇮🇳 Raipur, CHHATTISGARH, India

Krishna Institute of Medical Sciences (KIMS Hospital); 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Sri Jayadeva Institute of Cardiovascular Sciences and Research; 🇮🇳 Bangalore, KARNATAKA, India

Fortis Escorts Heart Centre

🇮🇳Raipur, CHHATTISGARH, India

Dr Satish Suryavanshi

Principal investigator

9826334404

drsatish_suryavanshi@yahoo.co.in