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

NCT00811616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-05-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sahajanand Medical Technologies Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Ashok Seth · Escorts Heart Institute & Research Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-07-31
Completion
2008-03-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00811616 on ClinicalTrials.gov