Literature DB >> 23253405

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

Ashok Seth1, Praveen Chandra, Nagendra S Chouhan, Ashok S Thakkar.   

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.

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Year:  2012        PMID: 23253405      PMCID: PMC3861257          DOI: 10.1016/j.ihj.2012.07.011

Source DB:  PubMed          Journal:  Indian Heart J        ISSN: 0019-4832


  34 in total

1.  Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial.

Authors:  A Kastrati; J Mehilli; J Dirschinger; F Dotzer; H Schühlen; F J Neumann; M Fleckenstein; C Pfafferott; M Seyfarth; A Schömig
Journal:  Circulation       Date:  2001-06-12       Impact factor: 29.690

2.  Clinical and quantitative coronary angiographic predictors of coronary restenosis: a comparative analysis from the balloon-to-stent era.

Authors:  N Mercado; E Boersma; W Wijns; B J Gersh; C A Morillo; V de Valk; G A van Es; D E Grobbee; P W Serruys
Journal:  J Am Coll Cardiol       Date:  2001-09       Impact factor: 24.094

3.  Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project.

Authors:  Jonathan R Nebeker; Renu Virmani; Charles L Bennett; Jennifer M Hoffman; Matthew H Samore; Jorge Alvarez; Charles J Davidson; June M McKoy; Dennis W Raisch; Brian K Whisenant; Paul R Yarnold; Steven M Belknap; Dennis P West; Jonathan E Gage; Richard E Morse; Gordana Gligoric; Laura Davidson; Marc D Feldman
Journal:  J Am Coll Cardiol       Date:  2005-12-01       Impact factor: 24.094

4.  Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden.

Authors:  Bo Lagerqvist; Stefan K James; Ulf Stenestrand; Johan Lindbäck; Tage Nilsson; Lars Wallentin
Journal:  N Engl J Med       Date:  2007-02-12       Impact factor: 91.245

5.  Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents.

Authors:  Adnan Kastrati; Julinda Mehilli; Jürgen Pache; Christoph Kaiser; Marco Valgimigli; Henning Kelbaek; Maurizio Menichelli; Manel Sabaté; Maarten J Suttorp; Dietrich Baumgart; Melchior Seyfarth; Matthias E Pfisterer; Albert Schömig
Journal:  N Engl J Med       Date:  2007-02-12       Impact factor: 91.245

6.  Clinical outcomes of stents versus balloon angioplasty in non-acute coronary artery disease. A meta-analysis of randomized controlled trials.

Authors:  Alain J Nordmann; Peter Hengstler; Bernd M Leimenstoll; Thomas Harr; James Young; Heiner C Bucher
Journal:  Eur Heart J       Date:  2004-01       Impact factor: 29.983

7.  Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries.

Authors:  W J van der Giessen; A M Lincoff; R S Schwartz; H M van Beusekom; P W Serruys; D R Holmes; S G Ellis; E J Topol
Journal:  Circulation       Date:  1996-10-01       Impact factor: 29.690

8.  Evidence for use of coronary stents. A hierarchical bayesian meta-analysis.

Authors:  James M Brophy; Patrick Belisle; Lawrence Joseph
Journal:  Ann Intern Med       Date:  2003-05-20       Impact factor: 25.391

9.  First-in-human study of the Endeavor ABT-578-eluting phosphorylcholine-encapsulated stent system in de novo native coronary artery lesions: Endeavor I Trial.

Authors:  Ian T Meredith; John Ormiston; Robert Whitbourn; I Patrick Kay; David Muller; Raoul Bonan; Jeffrey J Popma; Donald E Cutlip; Peter Fitzgerald; Ross Prpic; Richard E Kuntz
Journal:  EuroIntervention       Date:  2005-08       Impact factor: 6.534

10.  Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis.

Authors:  Julinda Mehilli; Robert A Byrne; Anna Wieczorek; Raisuke Iijima; Stefanie Schulz; Olga Bruskina; Jürgen Pache; Rainer Wessely; Albert Schömig; Adnan Kastrati
Journal:  Eur Heart J       Date:  2008-06-11       Impact factor: 29.983

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  3 in total

1.  Evaluation of clinical outcomes in patients undergoing dual vessel percutaneous coronary intervention using sirolimus-eluting coronary stent system in India.

Authors:  Prakash Chandwani; Jayesh Prajapati; Sanjay Porwal; Bhavesh Khambhati; Ashok Thakkar
Journal:  J Clin Diagn Res       Date:  2015-02-01

2.  Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent in De Novo Coronary Artery Disease: Results of the MANIPAL-FLEX Study.

Authors:  Ranjan Shetty; Jayesh Prajapati; Umesh Pai; Kiran Shetty
Journal:  Scientifica (Cairo)       Date:  2016-08-14

3.  Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry.

Authors:  Pedro A Lemos; Prakash Chandwani; Sudheer Saxena; Padma Kumar Ramachandran; Atul Abhyankar; Carlos M Campos; Julio Flavio Marchini; Micheli Zanotti Galon; Puneet Verma; Manjinder Singh Sandhu; Nikhil Parikh; Ashok Bhupali; Sharad Jain; Jayesh Prajapati
Journal:  BMJ Open       Date:  2016-02-17       Impact factor: 2.692

  3 in total

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