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Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial

NCT04310046 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 986

Last updated 2025-09-17

No results posted yet for this study

Summary

The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the safety and efficacy of angiography-guided complete revascularization performed after (within 1-45 days) with angiography-guided complete revascularization performed before (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.

Conditions

Interventions

PROCEDURE

PCI before TAVI

TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with ≥70% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.

PROCEDURE

PCI after TAVI

TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with ≥70% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Markus Kasel, MD · University Hospital, Zürich

  • Barbara E. Stähli, MD, eMBA · University Hospital, Zürich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2026-07-31
Completion
2031-07-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT04310046 on ClinicalTrials.gov