Non-Acute Coronary occlusIon Treated By Everolimus ELuting Stent - Full Text View

Sponsored by:	Spanish Society of Cardiology
Information provided by:	Spanish Society of Cardiology
ClinicalTrials.gov Identifier:	NCT00793221

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 III

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Everolimus Sirolimus

U.S. FDA Resources

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

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 ]

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
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
Everolimus-eluting stent: Active Comparator 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

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

Keywords provided by Spanish Society of Cardiology:

Coronary stent.
Restenosis.
Coronary artery disease.
Chronic total occlusion.

Study placed in the following topic categories:

Arterial Occlusive Diseases
Sirolimus
Everolimus
Heart Diseases
Clotrimazole
Myocardial Ischemia
Miconazole

Tioconazole
Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Disease
Coronary Occlusion
Coronary Artery Disease

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 15, 2009