Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
NCT ID: NCT01711931
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
240 participants
INTERVENTIONAL
2012-10-31
2013-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Everolimus-eluting bioresorbable vascular scaffold stents
Implantation of everolimus-eluting bioresorbable vascular scaffold stent
Everolimus-eluting stent
Implantation of everolimus-eluting stents
Biolimus-eluting stent
Implantation of biolimus-eluting stents
Interventions
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Implantation of everolimus-eluting bioresorbable vascular scaffold stent
Implantation of everolimus-eluting stents
Implantation of biolimus-eluting stents
Eligibility Criteria
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Inclusion Criteria
* ability and willingness to provide written informed consent
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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University of Freiburg
OTHER
Responsible Party
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Stéphane Cook, Prof
Principal Investigator
Principal Investigators
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Stéphane Cook, Professor
Role: STUDY_CHAIR
University of Freiburg
Mario Togni, Professor
Role: STUDY_DIRECTOR
University of Freiburg
Serban Puricel, MD
Role: PRINCIPAL_INVESTIGATOR
University of Freiburg
Locations
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Fribourg Cantonal Hospital
Fribourg, , Switzerland
Countries
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References
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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.
Bengueddache 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.
Kallinikou 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.
Puricel 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.
Other Identifiers
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043/12-CER-FR
Identifier Type: -
Identifier Source: org_study_id