Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent (CIBELES)
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.
|Coronary Artery Disease Coronary Occlusion Percutaneous Coronary Intervention||Device: Implantation of sirolimus-eluting coronary stent Device: Implantation of everolimus-eluting coronary stent||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Comparison Between Sirolimus-eluting and Everolimus-eluting Coronary Stents in Chronic Coronary Occlusions|
- In-stent late lumen loss at 9-month angiographic follow-up [ Time Frame: 9 months ]
- 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 ]
|Study Start Date:||November 2008|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Implantation of sirolimus-eluting coronary stent
Device: Implantation of sirolimus-eluting coronary stent
Implantation of sirolimus-eluting coronary stent after dilatation of the coronary occlusion
Active Comparator: Everolimus-eluting stent
Implantation of everolimus-eluting coronary stent
Device: Implantation of everolimus-eluting coronary stent
Implantation of everolimus-eluting coronary stent after dilatation of the coronary occlusion