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Indian Heart J. 2012 Nov-Dec;64(6):547-52. doi: 10.1016/j.ihj.2012.07.011. Epub 2012 Jul 27.

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

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1
Escorts Heart Institute & Research Centre, New Delhi, India.

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.

PMID:
23253405
PMCID:
PMC3861257
DOI:
10.1016/j.ihj.2012.07.011
[Indexed for MEDLINE]
Free PMC Article
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