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Sponsored by: |
Spanish Society of Cardiology |
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Information provided by: | Spanish Society of Cardiology |
ClinicalTrials.gov Identifier: | NCT00793221 |
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.
Condition | Intervention | Phase |
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Coronary Artery Disease Coronary Occlusion Percutaneous Coronary Intervention |
Device: Implantation of sirolimus-eluting coronary stent Device: Implantation of everolimus-eluting coronary stent |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Comparison Between Sirolimus-Eluting and Everolimus-Eluting Coronary Stents in Chronic Coronary Occlusions |
Estimated Enrollment: | 208 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sirolimus-eluting stent
Implantation of sirolimus-eluting coronary stent
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Device: Implantation of sirolimus-eluting coronary stent
Implantation of sirolimus-eluting coronary stent after dilatation of the coronary occlusion
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Everolimus-eluting stent: Active Comparator
Implantation of everolimus-eluting coronary stent
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Device: Implantation of everolimus-eluting coronary stent
Implantation of everolimus-eluting coronary stent after dilatation of the coronary occlusion
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Spanish Society of Cardiology ( Raul Moreno, MD ) |
Study ID Numbers: | CIBELES, HHLP003 |
Study First Received: | November 17, 2008 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00793221 |
Health Authority: | Spain: Ministry of Health |
Coronary stent. Restenosis. Coronary artery disease. Chronic total occlusion. |
Arterial Occlusive Diseases Sirolimus Everolimus Heart Diseases Clotrimazole Myocardial Ischemia Miconazole |
Tioconazole Vascular Diseases Ischemia Arteriosclerosis Coronary Disease Coronary Occlusion Coronary Artery Disease |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |