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

Primary Purpose

Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Implantation of sirolimus-eluting coronary stent

Implantation of everolimus-eluting coronary stent

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary stent., Restenosis., Coronary artery disease., Chronic total occlusion.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Sirolimus-eluting stent

Everolimus-eluting stent

Arm Description

Implantation of sirolimus-eluting coronary stent

Implantation of everolimus-eluting coronary stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Angiographic: rate of binary angiographic restenosis, rate of vessel re-occlusion, and in-segment late loss, at 9 months

Clinical: death, myocardial infarction, new revascularization, and angina status at 1 year.

Full Information

NCT ID

NCT00793221

First Posted

November 17, 2008

Last Updated

June 18, 2012

Sponsor

Raul Moreno

1. Study Identification

Unique Protocol Identification Number

NCT00793221

Brief Title

Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent

Acronym

CIBELES

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Raul Moreno

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sirolimus-eluting stent

Arm Type

Other

Arm Description

Implantation of sirolimus-eluting coronary stent

Arm Title

Everolimus-eluting stent

Arm Type

Active Comparator

Arm Description

Implantation of everolimus-eluting coronary stent

Intervention Type

Device

Intervention Name(s)

Implantation of sirolimus-eluting coronary stent

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Implantation of everolimus-eluting coronary stent

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

9 months

Secondary Outcome Measure Information:

Title

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

Title

Clinical: death, myocardial infarction, new revascularization, and angina status at 1 year.

Time Frame

9 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

25840644

Citation

Ruiz-Garcia J, Teles R, Rumoroso JR, Cyrne Carvalho H, Goicolea FJ, Moreu J, Mauri J, Mainar V, Garcia E, Moreno R; CIBELES investigators. Comparison between diabetic and non-diabetic patients after successful percutaneous coronary intervention for chronic total occlusions in the drug-eluting stent era. Rev Port Cardiol. 2015 Apr;34(4):263-70. doi: 10.1016/j.repc.2014.10.009. Epub 2015 Apr 1.

Results Reference

derived

PubMed Identifier

23403384

Citation

Moreno R, Garcia E, Teles R, Rumoroso JR, Cyrne Carvalho H, Goicolea FJ, Moreu J, Mauri J, Sabate M, Mainar V, Patricio L, Valdes M, Fernandez Vazquez F, Sanchez-Recalde A, Galeote G, Jimenez-Valero S, Almeida M, Lopez de Sa E, Calvo L, Plaza I, Lopez-Sendon JL, Martin JL; CIBELES Investigators. Randomized comparison of sirolimus-eluting and everolimus-eluting coronary stents in the treatment of total coronary occlusions: results from the chronic coronary occlusion treated by everolimus-eluting stent randomized trial. Circ Cardiovasc Interv. 2013 Feb;6(1):21-8. doi: 10.1161/CIRCINTERVENTIONS.112.000076. Epub 2013 Feb 12.

Results Reference

derived

PubMed Identifier

20542806

Citation

Moreno R, Garcia E, Teles RC, Almeida MS, Carvalho HC, Sabate M, Martin-Reyes R, Rumoroso JR, Galeote G, Goicolea FJ, Moreu J, Mainar V, Mauri J, Ferreira R, Valdes M, Perez de Prado A, Martin-Yuste V, Jimenez-Valero S, Sanchez-Recalde A, Calvo L, Lopez de Sa E, Macaya C, Lopez-Sendon JL. A randomised comparison between everolimus-eluting stent and sirolimus-eluting stent in chronic coronary total occlusions. Rationale and design of the CIBELES (non-acute Coronary occlusion treated by EveroLimus-Eluting Stent) trial. EuroIntervention. 2010 May;6(1):112-6.

Results Reference

derived

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Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent

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