Coronary Artery DiseasePhase 3CIBELESNCT00793221
Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent
A Phase 3 study testing Implantation of sirolimus-eluting coronary stent and Implantation of everolimus-eluting coronary stent in people with Coronary Artery Disease and Coronary Occlusion, run by Raul Moreno.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention
- What is being tested?
- Implantation of sirolimus-eluting coronary stent and Implantation of everolimus-eluting coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Randomized Comparison Between Sirolimus-eluting and Everolimus-eluting Coronary Stents in Chronic Coronary Occlusions
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.
- Being tested
- Implantation of sirolimus-eluting coronary stent, Implantation of everolimus-eluting coronary stent
- Keywords
- Coronary stent., Restenosis., Coronary artery disease., Chronic total occlusion.
- Medical subject headings
- Coronary Artery Disease, Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of sirolimus-eluting coronary stentDevice
Implantation of sirolimus-eluting coronary stent after dilatation of the coronary occlusion
Implantation of everolimus-eluting coronary stentDevice
Implantation of everolimus-eluting coronary stent after dilatation of the coronary occlusion
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus-eluting stent | Other | Implantation of sirolimus-eluting coronary stent Receives: Device: Implantation of sirolimus-eluting coronary stent |
| Everolimus-eluting stent | Active comparator | Implantation of everolimus-eluting coronary stent Receives: Device: Implantation of everolimus-eluting coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late lumen loss at 9-month angiographic follow-up
Measured: 9 months
Secondary outcomes (2)
Angiographic: rate of binary angiographic restenosis, rate of vessel re-occlusion, and in-segment late loss, at 9 months
Measured: 9 and 12 months
Clinical: death, myocardial infarction, new revascularization, and angina status at 1 year.
Measured: 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raul Moreno
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raul Moreno, Spanish Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793221
- Sponsor's protocol ID
- CIBELES
- Other IDs
- HHLP003
- Acronym
- CIBELES
- Status last verified
- Jun 2012
- First submitted
- 17 Nov 2008
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25840644Moreno 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.
PubMed 23403384Moreno 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.
PubMed 20542806
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between Sirolimus-eluting and Everolimus-eluting Coronary Stents in Chronic Coronary Occlusions
- ClinicalTrials.gov ID
- NCT00793221
- Acronym / sponsor ID
- CIBELES / CIBELES
- Keywords
- Coronary stent., Restenosis., Coronary artery disease., Chronic total occlusion.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Raul MorenoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2011 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus-eluting stent | Other | Device: Implantation of sirolimus-eluting coronary stentImplantation of sirolimus-eluting coronary stent |
| Everolimus-eluting stent | Active comparator | Device: Implantation of everolimus-eluting coronary stentImplantation of everolimus-eluting coronary stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of sirolimus-eluting coronary stentImplantation of sirolimus-eluting coronary stent after dilatation of the coronary occlusion | Device | Sirolimus-eluting stent |
| Implantation of everolimus-eluting coronary stentImplantation of everolimus-eluting coronary stent after dilatation of the coronary occlusion | Device | Everolimus-eluting stent |
Primary outcome
In-stent late lumen loss at 9-month angiographic follow-up
Time frame: 9 months
2 secondary outcomes
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
Clinical: death, myocardial infarction, new revascularization, and angina status at 1 year.
Time frame: 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
- Derived from this study: PubMed 25840644Ruiz-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.
- Derived from this study: PubMed 23403384Moreno 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.
- Derived from this study: PubMed 20542806Moreno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Implantation of sirolimus-eluting coronary stent and Implantation of everolimus-eluting coronary stent in people with Coronary Artery Disease and Coronary Occlusion, run by Raul Moreno.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent late lumen loss at 9-month angiographic follow-up (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00793221, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.