NCT00793221

Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent

Randomized Comparison Between Sirolimus-eluting and Everolimus-eluting Coronary Stents in Chronic Coronary Occlusions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Raul Moreno · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Coronary Occlusion
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	Implantation of sirolimus-eluting coronary stent	Implantation of sirolimus-eluting coronary stent after dilatation of the coronary occlusion
DEVICE	Implantation of everolimus-eluting coronary stent	Implantation of everolimus-eluting coronary stent after dilatation of the coronary occlusion

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-07-01
• First posted: 2008-11-19
• Last updated: 2012-06-19