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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Implantation of everolimus-eluting bioresorbable vascular scaffold stent
Implantation of everolimus-eluting stents
Implantation of biolimus-eluting stents
Sponsored by
University of Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring percutaneous coronary intervention, bioresorbable vascular scaffold stents, everolimus, biolimus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fribourg Cantonal Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Everolimus-eluting bioresorbable vascular scaffold stents

Everolimus-eluting stent

Biolimus-eluting stent

Arm Description

Outcomes

Primary Outcome Measures

Lumen Late Loss
as assessed by quantitative coronary angiogram

Secondary Outcome Measures

Device-oriented major adverse cardiac events
The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization
Patient-oriented major adverse cardiac events
The composite of all-cause mortality, any myocardial infarction and any revascularization

Full Information

First Posted
October 18, 2012
Last Updated
October 14, 2021
Sponsor
University of Freiburg
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1. Study Identification

Unique Protocol Identification Number
NCT01711931
Brief Title
Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
Acronym
EVERBIOII
Official Title
Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Freiburg

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
percutaneous coronary intervention, bioresorbable vascular scaffold stents, everolimus, biolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everolimus-eluting bioresorbable vascular scaffold stents
Arm Type
Active Comparator
Arm Title
Everolimus-eluting stent
Arm Type
Active Comparator
Arm Title
Biolimus-eluting stent
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Implantation of everolimus-eluting bioresorbable vascular scaffold stent
Intervention Type
Device
Intervention Name(s)
Implantation of everolimus-eluting stents
Intervention Type
Device
Intervention Name(s)
Implantation of biolimus-eluting stents
Primary Outcome Measure Information:
Title
Lumen Late Loss
Description
as assessed by quantitative coronary angiogram
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Device-oriented major adverse cardiac events
Description
The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization
Time Frame
6 months, 1, 2, 5 years
Title
Patient-oriented major adverse cardiac events
Description
The composite of all-cause mortality, any myocardial infarction and any revascularization
Time Frame
6 months, 1, 2, 5 years
Other Pre-specified Outcome Measures:
Title
Stent thrombosis
Description
possible, probable and definite stent thrombosis
Time Frame
up to 5 years
Title
Periprocedural Complications (occurring <48 hours after the Intervention)
Description
Type 4A MI Dissection Perforation
Time Frame
Periprocedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Cook, Professor
Organizational Affiliation
University of Freiburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mario Togni, Professor
Organizational Affiliation
University of Freiburg
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Serban Puricel, MD
Organizational Affiliation
University of Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fribourg Cantonal Hospital
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24398143
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.
Results Reference
result
PubMed Identifier
26766027
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.
Results Reference
derived
PubMed Identifier
25720622
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.
Results Reference
derived

Learn more about this trial

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

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