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.