NCT00811616

A Safety and Efficacy of Supralimus™ Core™ Sirolimus Eluting Stent at MAX DDHV Institute

Safety And Efficacy Evaluation of Sirolimus Eluting Supralimus-Core™ Stent at MAX DDHV Institute in the Treatment of de Novo Native Coronary Artery Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Sahajanand Medical Technologies Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: The primary objective of this study is to assess the safety and efficacy of the Supralimus - Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease. STUDY DESIGN: This is a single centre, prospective study. Approximately 105 patients were enrolled in the study. Patients were followed for twelve months post-procedure. All patients were to have a repeat angiography at 8 months. STUDY POPULATION: The study population consisted of approximately 105 patients with de novo native vessel obstructive coronary artery disease with no specific criteria. Patients from the daily practice were included. Patients had to meet all eligibility criteria for inclusion into the study. ENDPOINTS: The primary safety endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at 30 days. The primary efficacy endpoint is the in-stent binary restenosis rate at 8-month follow-up determined by off-line Quantitative Coronary Angiography. The following secondary efficacy endpoints were assessed * Angiographic success * Procedure success * Quantitative Coronary Angiography derived vessel parameters in-stent and 5 mm proximal and 5 mm distal from the edge of the stent: acute gain, MLD, % DS, late loss, mean diameter. In-stent pre-, post and at 8-month follow-up. * Clinically justified Target Lesion Revascularization (TLR) at 12 months The following secondary safety endpoints were assessed: * MACE until 12 months * Device related SAEs until 12 months * Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after 30 days until 12 months)

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Supralimus-Core™	Sirolimus Eluting Cobalt Chromium based coronary stent system
DEVICE	Supralimus™ Core™ Sirolimus eluting stent	Supralimus™ Core™ Sirolimus eluting stent intended to treat coronary artery disease.

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-07-01
• Completion: 2008-03-01
• First posted: 2008-12-19
• Last updated: 2025-05-16

Locations

1 site across 1 country: India