Clinical Trial: Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Comparison Between Sirolimus-eluting and Everolimus-eluting Coronary Stents in Chronic Coronary Occlusions
Brief Summary:
Chronic total coronary occlusions (CTO) have an especially high risk of angiographic restenosis, and need for new revascularization procedures. Drug-eluting coronary stents (DES) have demonstrated to significantly reduce the risk of restenosis and new revascularization procedures in comparison with bare-metal stents.
Most data on the efficacy of DES come from the sirolimus-eluting coronary stent Cypher (Cordis corp.), and paclitaxel-eluting coronary stent Taxus (Boston Sci.), and the Cypher stent is the only DES that has been randomly tested in CTO. Among second-generation DES, everolimus-eluting stent (EES) has shown excellent angiographic and clinical results, but this DES has not been studied in unfavourable scenario (such as CTO).
The aim of the CIBELES trial is to demonstrate the hypothesis that EES are equally effective in comparison with sirolimus-eluting stents in the treatment of CTO, in terms of angiographic efficacy considered as in-stent late lumen loss.
Detailed Summary:
Sponsor: Raul Moreno
Current Primary Outcome: In-stent late lumen loss at 9-month angiographic follow-up [ Time Frame: 9 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Angiographic: rate of binary angiographic restenosis, rate of vessel re-occlusion, and in-segment late loss, at 9 months [ Time Frame: 9 and 12 months ]
- Clinical: death, myocardial infarction, new revascularization, and angina status at 1 year. [ Time Frame: 9 and 12 months ]
Original Secondary Outcome: Same as current
Information By: Spanish Society of Cardiology
Dates:
Date Received: November 17, 2008
Date Started: November 2008
Date Completion:
Last Updated: June 18, 2012
Last Verified: June 2012
