Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raul Moreno, Spanish Society of Cardiology
ClinicalTrials.gov Identifier:
NCT00793221
First received: November 17, 2008
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

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
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Comparison Between Sirolimus-eluting and Everolimus-eluting Coronary Stents in Chronic Coronary Occlusions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spanish Society of Cardiology:

Primary Outcome Measures:
  • In-stent late lumen loss at 9-month angiographic follow-up [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Clinical: death, myocardial infarction, new revascularization, and angina status at 1 year. [ Time Frame: 9 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 207
Study Start Date: November 2008
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Spanish Society of Cardiology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Raul Moreno, Director of Invasive Cardiology, University Hospital La Paz, Madrid, Spain, Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT00793221     History of Changes
Other Study ID Numbers: CIBELES, HHLP003
Study First Received: November 17, 2008
Last Updated: June 18, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Spanish Society of Cardiology:
Coronary stent.
Restenosis.
Coronary artery disease.
Chronic total occlusion.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013