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

October 14, 2021 updated by: Stéphane Cook, Prof, University of Freiburg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Fribourg, Switzerland, 1708
        • Fribourg Cantonal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Biolimus-eluting stent
Device: Implantation of biolimus-eluting stents
ACTIVE_COMPARATOR: Everolimus-eluting stent
Device: Implantation of everolimus-eluting stents
ACTIVE_COMPARATOR: Everolimus-eluting bioresorbable vascular scaffold stents
Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lumen Late Loss
Time Frame: 9 months
as assessed by quantitative coronary angiogram
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-oriented major adverse cardiac events
Time Frame: 6 months, 1, 2, 5 years
The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization
6 months, 1, 2, 5 years
Patient-oriented major adverse cardiac events
Time Frame: 6 months, 1, 2, 5 years
The composite of all-cause mortality, any myocardial infarction and any revascularization
6 months, 1, 2, 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent thrombosis
Time Frame: up to 5 years
possible, probable and definite stent thrombosis
up to 5 years
Periprocedural Complications (occurring <48 hours after the Intervention)
Time Frame: Periprocedural
Type 4A MI Dissection Perforation
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (ESTIMATE)

October 22, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 043/12-CER-FR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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