Scope 2

SCOPE 2

Brief summary:

SCOPE-II is a sponsor-initiated, current care randomized, controlled, non-inferiority trial evaluating safety and clinical efficacy of the Symetis ACURATE neo compared to the Medtronic Evolut R bioprosthesis in transfemoral transcatheter aortic valve implantation.

Primary endpoints:

  • Composite of all-cause mortality or stroke at 1 year.

CERC Services:

  • Clinical trial documentation,
  • Submission,
  • Set-up activities,
  • eCRF / data-management,
  • Monitoring,
  • CEC,
  • DSMB,
  • CoreLab activities,
  • Clinical report

Countries:

UK, Germany, France, Denmark, Spain and Italy.

Center number:

20 centers.

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