Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sirolimus-eluting Stents With Biodegradable Polymer Versus an Everolimus-eluting Stents

NCT01443104

Coronary Artery Disease Angina Pectoris Myocardial Infarction

COMPLETED NA

Clinical Investigation for Everolimus Drug Eluting Stent

NCT06769217

Coronary Arterial Disease (CAD)

ACTIVE_NOT_RECRUITING PHASE4

Wall Shear Stress and Neointimal Healing Following PCI in Angulated Coronary Vessels

NCT02098876

Coronary Artery Disease

COMPLETED NA

A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI

NCT03440801

STEMI - ST Elevation Myocardial Infarction

COMPLETED NA

Sirolimus-Eluting Stents for Chronic Total Coronary Occlusions

NCT00258596

Coronary Artery Disease Coronary Disease Coronary Stenosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Coronary Occlusion Percutaneous Coronary Intervention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sirolimus-eluting stent

Implantation of sirolimus-eluting coronary stent

Group Type OTHER

Implantation of sirolimus-eluting coronary stent

Intervention Type DEVICE

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

Everolimus-eluting stent

Implantation of everolimus-eluting coronary stent

Group Type ACTIVE_COMPARATOR

Implantation of everolimus-eluting coronary stent

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implantation of sirolimus-eluting coronary stent

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

Intervention Type DEVICE

Implantation of everolimus-eluting coronary stent

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No