Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent

NCT00793221 | Completed Phase 3 DMC

• 2 other identifiers: CIBELESHHLP003
• Study Type: interventional
• Target: 207
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Coronary Occlusion; Percutaneous Coronary Intervention

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  9 months

Secondary Outcomes (2)

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

  9 and 12 months

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

  9 and 12 months

Study Arms (2)

Sirolimus-eluting stent

OTHER

Implantation of sirolimus-eluting coronary stent

Device: Implantation of sirolimus-eluting coronary stent

Everolimus-eluting stent

ACTIVE COMPARATOR

Implantation of everolimus-eluting coronary stent

Device: Implantation of everolimus-eluting coronary stent

Interventions

Implantation of sirolimus-eluting coronary stent DEVICE

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

Sirolimus-eluting stent

Implantation of everolimus-eluting coronary stent DEVICE

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

Everolimus-eluting stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Raul Moreno: lead

Related Publications (3)

• 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.

  PMID: 25840644 DERIVED

• 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.

  PMID: 23403384 DERIVED

• 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.

  PMID: 20542806 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Occlusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Invasive Cardiology, University Hospital La Paz, Madrid, Spain

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2011
• Last Updated: June 19, 2012

Record last verified: 2012-06