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The TransCatheter Valve and Vessels Trial

NCT03424941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-01-09

No results posted yet for this study

Summary

The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.

Conditions

  • Aortic Stenosis
  • Multi Vessel Coronary Artery Disease
  • TAVI
  • CABG
  • PCI
  • Fractional Flow Reserve

Interventions

DEVICE

FFR-guided PCI and TAVI

Treatment of subjects with multivessel coronary artery disease and aortic stenosis for FFR-guided PCI and TAVI (Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO)

DEVICE

CABG and SAVR

Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Maatschap Cardiologie Zwolle

    lead OTHER

Principal Investigators

  • prof. Elvin Kedhi, MD, PhD · Hopital Erasme, Brussels, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2024-06-26
Completion
2024-06-26

Countries

  • Austria
  • Denmark
  • France
  • Germany
  • Greece
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT03424941 on ClinicalTrials.gov