Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Aortic Stenosis
  • Coronary (Artery) Disease
  • PCI
  • TAVI
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The prevalence of coronary artery disease in patients with severe aortic stenosis is high. About 30-60% of patients undergoing TAVI exhibit coexisting coronary artery disease. Optimal timing of coronary revascularization in patients with severe aortic stenosis and concomitant coronary artery disease...

The prevalence of coronary artery disease in patients with severe aortic stenosis is high. About 30-60% of patients undergoing TAVI exhibit coexisting coronary artery disease. Optimal timing of coronary revascularization in patients with severe aortic stenosis and concomitant coronary artery disease undergoing TAVI is uncertain. The goal of this investigator-initiated, randomized, multicenter, two-arm, open-label, non-inferiority trial is to compare two treatment strategies that are currently performed in clinical practice: PCI before TAVI versus PCI after TAVI in patients with severe aortic stenosis and concomitant coronary artery disease. In this trial, consecutive patients with severe aortic stenosis and concomitant coronary artery disease accepted for TAVI and PCI by the Heart Team will be randomized in a 1:1 ratio to either FFR-guided complete coronary revascularization before (within 1-40 days) or after (within 1-40 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®. For both treatment groups, suitable lesions with FFR?0.80 or >90% diameter stenosis on coronary angiography in a coronary artery ?2.5 mm in diameter are considered significant. TAVI and PCI will be performed according to current guidelines.

Tracking Information

NCT #
NCT04310046
Collaborators
Not Provided
Investigators
Principal Investigator: Markus Kasel, MD University Hospital, Zürich Principal Investigator: Barbara E. Stähli, MD, eMBA University Hospital, Zürich