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Completed

NCT Number: NCT00793221

Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Occlusion Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implantation of sirolimus-eluting coronary stent

Device

Implantation of sirolimus-eluting coronary stent after dilatation of the coronary occlusion

Implantation of everolimus-eluting coronary stent

Device

Implantation of everolimus-eluting coronary stent after dilatation of the coronary occlusion

Primary outcomes

  1. In-stent late lumen loss at 9-month angiographic follow-up

    Time frame: 9 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Raul Moreno

Other

Registry information

Official study title

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

Acronym: CIBELES

Important dates

Study start
2008
Primary completion
2011
First posted
Nov 19, 2008
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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