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

Sponsor
University of Freiburg (Other)
Overall Status
Completed
CT.gov ID
NCT01711931
Collaborator
(none)
240
1
3
14
17.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent
  • Device: Implantation of everolimus-eluting stents
  • Device: Implantation of biolimus-eluting stents
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Everolimus-eluting bioresorbable vascular scaffold stents

Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent

Active Comparator: Everolimus-eluting stent

Device: Implantation of everolimus-eluting stents

Active Comparator: Biolimus-eluting stent

Device: Implantation of biolimus-eluting stents

Outcome Measures

Primary Outcome Measures

  1. Lumen Late Loss [9 months]

    as assessed by quantitative coronary angiogram

Secondary Outcome Measures

  1. Device-oriented major adverse cardiac events [6 months, 1, 2, 5 years]

    The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization

  2. Patient-oriented major adverse cardiac events [6 months, 1, 2, 5 years]

    The composite of all-cause mortality, any myocardial infarction and any revascularization

Other Outcome Measures

  1. Stent thrombosis [up to 5 years]

    possible, probable and definite stent thrombosis

  2. Periprocedural Complications (occurring <48 hours after the Intervention) [Periprocedural]

    Type 4A MI Dissection Perforation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fribourg Cantonal Hospital Fribourg Switzerland 1708

Sponsors and Collaborators

  • University of Freiburg

Investigators

  • Study Chair: Stéphane Cook, Professor, University of Freiburg
  • Study Director: Mario Togni, Professor, University of Freiburg
  • Principal Investigator: Serban Puricel, MD, University of Freiburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stéphane Cook, Prof, Principal Investigator, University of Freiburg
ClinicalTrials.gov Identifier:
NCT01711931
Other Study ID Numbers:
  • 043/12-CER-FR
First Posted:
Oct 22, 2012
Last Update Posted:
Oct 22, 2021
Last Verified:
May 1, 2014
Keywords provided by Stéphane Cook, Prof, Principal Investigator, University of Freiburg
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2021