Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent

Coronary Artery Disease Clinical Trial

— CIBELES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793221
• Other study ID #: CIBELES
• Secondary ID: HHLP003
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2008
• Last updated: June 18, 2012
• Start date: November 2008

Study information

• Verified date: June 2012
• Source: Spanish Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Occlusion
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Device:
• Implantation of sirolimus-eluting coronary stent
Implantation of sirolimus-eluting coronary stent after dilatation of the coronary occlusion
• Implantation of everolimus-eluting coronary stent
Implantation of everolimus-eluting coronary stent after dilatation of the coronary occlusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Raul Moreno

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late lumen loss at 9-month angiographic follow-up		9 months	No
Secondary	Angiographic: rate of binary angiographic restenosis, rate of vessel re-occlusion, and in-segment late loss, at 9 months		9 and 12 months	Yes
Secondary	Clinical: death, myocardial infarction, new revascularization, and angina status at 1 year.		9 and 12 months	Yes