Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents

NCT01711931 | Completed Phase 4 DMC

• 1 other identifier: 043/12-CER-FR
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention; bioresorbable vascular scaffold stents; everolimus; biolimus

Outcome Measures

Primary Outcomes (1)

• Lumen Late Loss

  as assessed by quantitative coronary angiogram

  9 months

Secondary Outcomes (2)

• Device-oriented major adverse cardiac events

  6 months, 1, 2, 5 years

• Patient-oriented major adverse cardiac events

  6 months, 1, 2, 5 years

Other Outcomes (2)

• Stent thrombosis

  up to 5 years

• Periprocedural Complications (occurring <48 hours after the Intervention)

  Periprocedural

Study Arms (3)

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Freiburg: lead

Study Sites (1)

Fribourg Cantonal Hospital

Fribourg, 1708, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 24398143 RESULT

• 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.

  PMID: 39323753 DERIVED

• 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.

  PMID: 26766027 DERIVED

• 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.

  PMID: 25720622 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Stéphane Cook, Professor

  University of Freiburg

  STUDY CHAIR

• Mario Togni, Professor

  University of Freiburg

  STUDY DIRECTOR

• Serban Puricel, MD

  University of Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 22, 2021

Record last verified: 2014-05

Locations

CH (1)