1. A first-in-man study of sirolimus-eluting, biodegradable polymer coated cobalt chromium stent in real life patients.
- Author
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Seth A, Chandra P, Chouhan NS, and Thakkar AS
- Subjects
- Absorbable Implants, Chromium, Coated Materials, Biocompatible, Cobalt, Coronary Angiography, Coronary Disease diagnostic imaging, Female, Humans, Male, Middle Aged, Polymers, Prospective Studies, Treatment Outcome, Coronary Disease therapy, Drug-Eluting Stents, Immunosuppressive Agents administration & dosage, Sirolimus administration & dosage
- 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., (Copyright © 2012 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.)
- Published
- 2012
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