Clinical trial NCT01711931: Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
Official title: Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: percutaneous coronary intervention
bioresorbable vascular scaffold stents
everolimus
biolimus
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2012-10-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.


Eligibility criteria: Inclusion Criteria:

* elective PCI
* ability and willingness to provide written informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Lumen Late Loss
timeFrame: 9 months
Secondary outcomes:
measure: Device-oriented major adverse cardiac events
timeFrame: 6 months, 1, 2, 5 years
measure: Patient-oriented major adverse cardiac events
timeFrame: 6 months, 1, 2, 5 years
Other outcomes:
measure: Stent thrombosis
timeFrame: up to 5 years
measure: Periprocedural Complications (occurring <48 hours after the Intervention)
timeFrame: Periprocedural
Locations:
city: Fribourg
country: Switzerland
facility: Fribourg Cantonal Hospital
Study officials:
affiliation: University of Freiburg
name: Stéphane Cook, Professor
role: STUDY_CHAIR
affiliation: University of Freiburg
name: Mario Togni, Professor
role: STUDY_DIRECTOR
affiliation: University of Freiburg
name: Serban Puricel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.