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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/048054
Enrollment
500
Registered
2022-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: I259- Chronic ischemic heart disease, unspecified

Interventions

None listed

Sponsors

Sahajanand Laser Technology Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients implanted with FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent System

Exclusion criteria

Exclusion criteria: Patients who are not implanted with FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent System

Design outcomes

Primary

MeasureTime frame
Target Lesion Failure which is defined as a composite of cardiovascular death, target vessel myocardial infarction (TV-MI) and clinically driven target lesion revascularizationTimepoint: 12 Months—

Secondary

MeasureTime frame
Cardiovascular Death Target Vessel Myocardial Infarction Clinically-Driven TLR Stent Thrombosis Target vessel failure Target vessel revascularizationTimepoint: 5 years—

Countries

India

Contacts

Public ContactMs Preeti Vani

Cardinova Institute of Medical Science

nitishgarg@yahoo.com9736088888

Outcome results

None listed

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