Coronary Artery DiseaseEverBioNCT01472705
Everolimus- Versus Biolimus-Eluting Stents in All-Comers
An observational study of Coronary Artery Disease, run by University of Freiburg at 1 site in Switzerland.
Trial summary
This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer through 3 years of follow-up. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 814 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2010to Nov 2011
- Phase
- Observational
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients treated at our institution with at least one BES or EES
Who may be able to join
- all patients with at least one BES or EES for de novo stenosis
Who cannot join
- patients with at least one non-study stent
- patients with both study stent
- patients with life expectancy < 3 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cardiology, university Fribourg Medical Center
Fribourg, Canton of Fribourg, 1708
About this study
Official title: Long-Term Comparison of Everolimus-Eluting and Biolimus-Eluting Stents in All-Comer Patients
This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer through 3 years of follow-up.
Read the detailed description
A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The primary endpoint was a composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) at two-year follow-up.
- Conditions
- Coronary Artery Disease
- Keywords
- drug-eluting coronary stent, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| everolimus-eluting stents (EES) | Second-generation everolimus-eluting stents (EES) have been shown to be superior to the first-generation paclitaxel eluting stents (PES) in terms of safety and efficacy. | |
| biolimus-eluting stents (BES) | Third generation biolimus-eluting stents (BES) have been shown to be superior to the PES and non inferior to first-generation sirolimus eluting stents in terms of safety and efficacy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Death, Myocardial Infarction and Target Vessel Revascularization
The primary outcome is the above mentioned composite of adverse events in order to measure their cumulative incidence (i.e. the rate of occurrence of such events in the study population over a predefined time periode).
Measured: up to 24 months
Secondary outcomes (2)
Cardiovascular death
Measured: up to 24 months
Any Revascularization
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stéphane Cook, Prof, University of Freiburg
- Investigators
- Stéphane P Cook, MD, Study chair, University FribourgMario Togni, MD, Study director, University FribourgMarkus Oberhänsli, MD, Principal investigator, University Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472705
- Sponsor's protocol ID
- 003-REP-CER-FR
- Acronym
- EverBio
- Status last verified
- Dec 2015
- First submitted
- 30 Aug 2011
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Puricel S, Oberhansli M, Guntern P, Lehmann S, Goy JJ, Arroyo D, Villeneuve H, Baeriswyl G, Stauffer JC, Togni M, Cook S. Long-term comparison of everolimus-eluting and biolimus-eluting stents. EuroIntervention. 2013 Jul;9(3):336-44. doi: 10.4244/EIJV9I3A55.
PubMed 23482296Arroyo D, Togni M, Puricel S, Gerard B, Sonja L, Corpataux N, Villeneuve H, Boute E, Stauffer JC, Goy JJ, Cook S. Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial. Trials. 2014 Jan 7;15:9. doi: 10.1186/1745-6215-15-9.
PubMed 24398143
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Comparison of Everolimus-Eluting and Biolimus-Eluting Stents in All-Comer Patients
- ClinicalTrials.gov ID
- NCT01472705
- Acronym / sponsor ID
- EverBio / 003-REP-CER-FR
- Conditions
- Coronary Artery Disease
- Keywords
- drug-eluting coronary stent, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Nov 2011 (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.
This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer through 3 years of follow-up.
Detailed description
A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The primary endpoint was a composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) at two-year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| everolimus-eluting stents (EES) | – | –Second-generation everolimus-eluting stents (EES) have been shown to be superior to the first-generation paclitaxel eluting stents (PES) in terms of safety and efficacy. |
| biolimus-eluting stents (BES) | – | –Third generation biolimus-eluting stents (BES) have been shown to be superior to the PES and non inferior to first-generation sirolimus eluting stents in terms of safety and efficacy. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients treated at our institution with at least one BES or EES
Key inclusion criteria (1 listed)
- all patients with at least one BES or EES for de novo stenosis
Key exclusion criteria (3 listed)
- patients with at least one non-study stent
- patients with both study stent
- patients with life expectancy < 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of Death, Myocardial Infarction and Target Vessel Revascularization
Time frame: up to 24 months
The primary outcome is the above mentioned composite of adverse events in order to measure their cumulative incidence (i.e. the rate of occurrence of such events in the study population over a predefined time periode).
2 secondary outcomes
Cardiovascular death
Time frame: up to 24 months
Any Revascularization
Time frame: up to 24 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 3 Dec 2015.
- Results publication: PubMed 23482296Puricel S, Oberhansli M, Guntern P, Lehmann S, Goy JJ, Arroyo D, Villeneuve H, Baeriswyl G, Stauffer JC, Togni M, Cook S. Long-term comparison of everolimus-eluting and biolimus-eluting stents. EuroIntervention. 2013 Jul;9(3):336-44. doi: 10.4244/EIJV9I3A55.
- Results publication: PubMed 24398143Arroyo D, Togni M, Puricel S, Gerard B, Sonja L, Corpataux N, Villeneuve H, Boute E, Stauffer JC, Goy JJ, Cook S. Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial. Trials. 2014 Jan 7;15:9. doi: 10.1186/1745-6215-15-9.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Stéphane P Cook, MD study chair
University Fribourg
Mario Togni, MD study director
University Fribourg
Markus Oberhänsli, MD principal investigator
University Fribourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Freiburg at 1 site in Switzerland.
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 1 inclusion and 3 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Composite of Death, Myocardial Infarction and Target Vessel Revascularization (time frame: up to 24 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 NCT01472705, which also lists 2 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 3 Dec 2015.