NCT03424941

The TransCatheter Valve and Vessels Trial

TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients with Coronary MultiVessel Disease and Aortic Valve Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Maatschap Cardiologie Zwolle · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective, randomized, controlled, open label, multicenter, international, non-inferiority trial If the Heart Team decides that a coronary revascularization and aortic valve replacement is needed and the patient complies with inclusion and exclusion criteria then the patient will be randomized in a 1:1 fashion between FFR-guided PCI + TAVI and CABG + SAVR. Patients will receive optimal medical treatment at discharge. Follow-up will be performed at 30 days and at one year. During the 30 day follow-up visit (after TAVI) patients will be evaluated for symptoms of angina.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-05-31
• Primary completion: 2024-06-26
• Completion: 2024-06-26
• First posted: 2018-02-07
• Last updated: 2025-01-09

Locations

20 sites across 10 countries: Austria, Denmark, France, Germany, Greece, Netherlands, Poland, Portugal, Slovakia, Spain