Coronary Artery DiseasePhase 4EVERBIOIINCT01711931
Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
A Phase 4 study testing Implantation of everolimus-eluting bioresorbable vascular scaffold stent, Implantation of everolimus-eluting stents and Implantation of biolimus-eluting stents in people with Coronary Artery Disease, run by University of Freiburg at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents. The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Implantation of everolimus-eluting bioresorbable vascular scaffold stent, Implantation of everolimus-eluting stents and Implantation of biolimus-eluting stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to Dec 2013
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective PCI
- ability and willingness to provide written informed consent
Who cannot join
- ST-elevation myocardial infarction in the previous 48 hours
- moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and <30ml/min respectively)
- known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.
The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.
- Conditions
- Coronary Artery Disease
- Being tested
- Implantation of everolimus-eluting bioresorbable vascular scaffold stent, Implantation of everolimus-eluting stents, Implantation of biolimus-eluting stents
- Keywords
- percutaneous coronary intervention, bioresorbable vascular scaffold stents, everolimus, biolimus
- 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.
Implantation of everolimus-eluting bioresorbable vascular scaffold stentDevice
Implantation of everolimus-eluting stentsDevice
Implantation of biolimus-eluting stentsDevice
| Study group | Role | What they receive |
|---|---|---|
| Everolimus-eluting bioresorbable vascular scaffold stents | Active comparator | Not described Receives: Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent |
| Everolimus-eluting stent | Active comparator | Not described Receives: Device: Implantation of everolimus-eluting stents |
| Biolimus-eluting stent | Active comparator | Not described Receives: Device: Implantation of biolimus-eluting stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumen Late Loss
as assessed by quantitative coronary angiogram
Measured: 9 months
Secondary outcomes (2)
Device-oriented major adverse cardiac events
The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization
Measured: 6 months, 1, 2, 5 years
Patient-oriented major adverse cardiac events
The composite of all-cause mortality, any myocardial infarction and any revascularization
Measured: 6 months, 1, 2, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 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 Cook, Professor, Study chair, University of FreiburgMario Togni, Professor, Study director, University of FreiburgSerban Puricel, MD, Principal investigator, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711931
- Sponsor's protocol ID
- 043/12-CER-FR
- Acronym
- EVERBIOII
- Status last verified
- May 2014
- First submitted
- 18 Oct 2012
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arroyo 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 24398143Bengueddache S, Cook M, Lehmann S, Arroyo D, Togni M, Puricel S, Cook S. Ten-year clinical outcomes of everolimus- and biolimus-eluting coronary stents vs. everolimus-eluting bioresorbable vascular scaffolds-insights from the EVERBIO-2 trial. Front Cardiovasc Med. 2024 Sep 10;11:1426348. doi: 10.3389/fcvm.2024.1426348. eCollection 2024.
PubMed 39323753Kallinikou Z, Arroyo D, Togni M, Lehman S, Corpataux N, Cook M, Muller O, Baeriswyl G, Stauffer JC, Goy JJ, Puricel SG, Cook S. Vascular response to everolimus- and biolimus-eluting coronary stents versus everolimus-eluting bioresorbable scaffolds--an optical coherence tomography substudy of the EVERBIO II trial. Swiss Med Wkly. 2016 Jan 14;146:w14274. doi: 10.4414/smw.2016.14274. eCollection 2016.
PubMed 26766027Puricel S, Arroyo D, Corpataux N, Baeriswyl G, Lehmann S, Kallinikou Z, Muller O, Allard L, Stauffer JC, Togni M, Goy JJ, Cook S. Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds. J Am Coll Cardiol. 2015 Mar 3;65(8):791-801. doi: 10.1016/j.jacc.2014.12.017.
PubMed 25720622
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
- ClinicalTrials.gov ID
- NCT01711931
- Acronym / sponsor ID
- EVERBIOII / 043/12-CER-FR
- Conditions
- Coronary Artery Disease
- Keywords
- percutaneous coronary intervention, bioresorbable vascular scaffold stents, everolimus, biolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Oct 2012 (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.
The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.
The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Everolimus-eluting bioresorbable vascular scaffold stents | Active comparator | Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent |
| Everolimus-eluting stent | Active comparator | Device: Implantation of everolimus-eluting stents |
| Biolimus-eluting stent | Active comparator | Device: Implantation of biolimus-eluting stents |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective PCI
- ability and willingness to provide written informed consent
Key exclusion criteria (3 listed)
- ST-elevation myocardial infarction in the previous 48 hours
- moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and <30ml/min respectively)
- known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication
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 everolimus-eluting bioresorbable vascular scaffold stent | Device | Everolimus-eluting bioresorbable vascular scaffold stents |
| Implantation of everolimus-eluting stents | Device | Everolimus-eluting stent |
| Implantation of biolimus-eluting stents | Device | Biolimus-eluting stent |
Primary outcome
Lumen Late Loss
Time frame: 9 months
as assessed by quantitative coronary angiogram
2 secondary outcomes
Device-oriented major adverse cardiac events
Time frame: 6 months, 1, 2, 5 years
Patient-oriented major adverse cardiac events
Time frame: 6 months, 1, 2, 5 years
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 22 Oct 2021.
- 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.
- Derived from this study: PubMed 39323753Bengueddache S, Cook M, Lehmann S, Arroyo D, Togni M, Puricel S, Cook S. Ten-year clinical outcomes of everolimus- and biolimus-eluting coronary stents vs. everolimus-eluting bioresorbable vascular scaffolds-insights from the EVERBIO-2 trial. Front Cardiovasc Med. 2024 Sep 10;11:1426348. doi: 10.3389/fcvm.2024.1426348. eCollection 2024.
- Derived from this study: PubMed 26766027Kallinikou Z, Arroyo D, Togni M, Lehman S, Corpataux N, Cook M, Muller O, Baeriswyl G, Stauffer JC, Goy JJ, Puricel SG, Cook S. Vascular response to everolimus- and biolimus-eluting coronary stents versus everolimus-eluting bioresorbable scaffolds--an optical coherence tomography substudy of the EVERBIO II trial. Swiss Med Wkly. 2016 Jan 14;146:w14274. doi: 10.4414/smw.2016.14274. eCollection 2016.
- Derived from this study: PubMed 25720622Puricel S, Arroyo D, Corpataux N, Baeriswyl G, Lehmann S, Kallinikou Z, Muller O, Allard L, Stauffer JC, Togni M, Goy JJ, Cook S. Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds. J Am Coll Cardiol. 2015 Mar 3;65(8):791-801. doi: 10.1016/j.jacc.2014.12.017.
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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.
Stéphane Cook, Professor study chair
University of Freiburg
Mario Togni, Professor study director
University of Freiburg
Serban Puricel, MD principal investigator
University of Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Implantation of everolimus-eluting bioresorbable vascular scaffold stent, Implantation of everolimus-eluting stents and Implantation of biolimus-eluting stents in people with 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 2 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 22 Oct 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Lumen Late Loss (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 NCT01711931, which also lists 4 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 22 Oct 2021.