Elsevier

Indian Heart Journal

Volume 64, Issue 6, November–December 2012, Pages 547-552
Indian Heart Journal

Original article
A first-in-man study of sirolimus-eluting, biodegradable polymer coated cobalt chromium stent in real life patients

https://doi.org/10.1016/j.ihj.2012.07.011Get rights and content
Under a Creative Commons license
open access

Abstract

Introduction

Despite considerable benefits associated with current drug-eluting stents, continued attention to the safety, efficacy, and deliverability of available drug-eluting stent has led to the development of newer stent.

Methods

This study was a single-centre, prospective, non-randomized, first-in-man study which included clinical follow-up data was collected at 1, 8 and 12 months after the procedure. The study included 105 patients with de novo native coronary artery lesions including multi-vessel disease treated with Supralimus-Core® stent. Repeat angiography was performed 8 months post-stent implantation.

Results

At quantitative coronary angiography 8-month luminal late loss was 0.39 ± 0.33 mm in-stent and 0.33 ± 0.35 mm in-segment. The incidence of any major adverse cardiac event at 30 days, 8 months and 12 months was 1 (1%), 6 (6%) and 7 (7%) respectively.

Conclusion

This study demonstrates that the Supralimus-Core® SES is a safe and effective treatment for patients with obstructive coronary artery disease.

ClinicalTrials.gov ID: NCT00811616.

Keywords

Coronary artery disease
Drug-eluting stent
Sirolimus
First-in-man

Cited by (0)

The institution at which the work was performed: Max Devki Devi Heart & Vascular Institute, 2, Press Enclave Road, Saket, New Delhi 110 017, India. Tel.: +91 9810125370; fax: +91 11 26510050.