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Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent (CIBELES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00793221
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : June 19, 2012
Information provided by (Responsible Party):
Raul Moreno, Spanish Society of Cardiology

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Occlusion Percutaneous Coronary Intervention Device: Implantation of sirolimus-eluting coronary stent Device: Implantation of everolimus-eluting coronary stent Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
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
Study Start Date : November 2008
Actual Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Sirolimus-eluting stent
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

Primary Outcome Measures :
  1. In-stent late lumen loss at 9-month angiographic follow-up [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Clinical: death, myocardial infarction, new revascularization, and angina status at 1 year. [ Time Frame: 9 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients ≥ 18 year-old.
  • A total occlusion (TIMI 0-1) with an estimated time of occlusion > 2 weeks.
  • Symptomatic or silent ischaemia, or viable myocardium.
  • The occlusion is suitable for percutaneous coronary intervention.
  • The guidewire has crossed the occlusion, and the occlusion has been dilated with balloon or other device.

Exclusion Criteria:

  • Acute myocardial infarction in the myocardial area supplied by the target vessel within 2 weeks before the inclusion in the study.
  • The lesion can not be crossed with the guidewire and balloon angioplasty.
  • The vessel has been previously treated percutaneously.
  • The lesion is not suitable for a 2.25-3.5 coronary stent implantation.
  • The patient is not willing to undergo an angiographic follow-up.
  • The patient has contraindications for prolonged double (aspirin plus clopidogrel) anti-platelet therapy (e.g. allergy to aspirin, need for chronic oral anti-coagulation, or scheduled surgical intervention within 12 months.
  • Pregnancy or absence of pregnancy test in women of childbearing age.
  • Chronic renal failure (creatinine plasmatic values > 3.0 mg/dl).
  • Plasmatic platelet count < 100.000 mm-3 or > 700.000 mm-3.
  • The patient has a severe non-cardiac disease that limits his/her life expectancy to < 1 year.
  • The patient is currently included in other randomized trial.

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Raul Moreno, Director of Invasive Cardiology, University Hospital La Paz, Madrid, Spain, Spanish Society of Cardiology Identifier: NCT00793221    
Other Study ID Numbers: CIBELES
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012
Keywords provided by Raul Moreno, Spanish Society of Cardiology:
Coronary stent.
Coronary artery disease.
Chronic total occlusion.
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents