Study to check the safety and performance of stent in all comer patients with de novo coronary artery disease .

Completed

• Conditions: Chronic ischemic heart disease, unspecified,

• Registration Number: CTRI/2022/12/048054
• Lead Sponsor: Sahajanand Laser Technology Ltd

Brief Summary

A retrospective, single-arm, multi-center, observational, post-market clinical follow-up study to evaluate the safety and performance of FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent System in patients with de novo coronary artery disease under real-world settings. The clinical endpoints are target lesion failure, cardiovascular death, target vessel myocardial infarction, clinically-driven target lesion revascularisation (CD-TLR), stent thrombosis (ST), target vessel failure (TVF), target vessel revascularization at 12 months, 3 years, 5 years follow-up. Total Number of 500 patients will be enrolled who have been implanted with FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent .

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

All patients implanted with FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent System.

Exclusion Criteria

Patients who are not implanted with FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent System.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure which is defined as a composite of cardiovascular death, target vessel myocardial	12 Months
infarction (TV-MI) and clinically driven target lesion revascularization	12 Months

Secondary Outcome Measures

Name	Time	Method
Cardiovascular Death	Target Vessel Myocardial Infarction

Trial Locations

Locations (5)

Cardinova Institute of Medical Science; 🇮🇳 Jalandhar, PUNJAB, India

CAREMAX Hospital; 🇮🇳 Jalandhar, PUNJAB, India

EMC Super Speciality Hospital; 🇮🇳 Amritsar, PUNJAB, India

Moga Medicity Hospital; 🇮🇳 Moga, PUNJAB, India

Sunshine Global Hospital; 🇮🇳 Surat, GUJARAT, India

Cardinova Institute of Medical Science

🇮🇳Jalandhar, PUNJAB, India

Dr Nitish Garg

Principal investigator

9736088888

nitishgarg@yahoo.com