Compare Absorb

COMPARE ABSORB

Brief summary:

This is a multi­centre, single-blind, prospective randomized investigator-driven trial that will include 2100 patients in 10 countries.

Included patients will present a high-risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent percutaneous coronary intervention.

Once included in the study, patient will receive either Absorb scaffold or Xience stent and will be followed for 5 years.

The results of this study will help to assess the non­inferiority of the everolimus­eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure(TLF) at 1 year and the superiority of the BRS to the EES in TLF between 1 and 5 years.

Primary endpoints:

  • Target lesion failure (TLF) as defined as a composite of
    • Cardiac death
    • Myocardial infarction (MI) in target vessel territory (SCAI consensus for periprocedural MI, 3rd universal definition for spontaneous or other MI)
    • Clinically Indicated Target lesion revascularization

CERC Services:

  • Regulatory Submissions
  • Project management
  • Contract Managment
  • Monitoring
  • Data Management
  •  AE Reporting
  • Organization of DSMB

Countries:

  • Belgium
  • Czech Republic
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Center number:

49 centers managed by CERC.

 

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