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

NCT01711931 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-10-22

No results posted yet for this study

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

Interventions

DEVICE

Implantation of everolimus-eluting bioresorbable vascular scaffold stent

DEVICE

Implantation of everolimus-eluting stents

DEVICE

Implantation of biolimus-eluting stents

Sponsors & Collaborators

  • University of Freiburg

    lead OTHER

Principal Investigators

  • Stéphane Cook, Professor · University of Freiburg

  • Mario Togni, Professor · University of Freiburg

  • Serban Puricel, MD · University of Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01711931 on ClinicalTrials.gov