PeRcutaneous cOronary intervention before Transcatheter Aortic Valve Implantation trial

Phase 4

Recruiting

Conditions: Coronary artery disease / Aortic valve stenosis
10011082

Registration Number: NL-OMON56109

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 466

Inclusion Criteria

- Patients schedueled for TAVI; AND
- Concomitant coronary artery disease.

Exclusion Criteria

- an unprotected left main stenosis (no patent bypass graft on the LAD or RCx)
> 50% or left main equivalent;
- Significant native coronary artery disease, but patent bypass surgery stents;
- Contraindication for DAPT;
- Patient with life expectancy < 1 year

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be a composite endpoint consisting of all-cause<br /><br>mortality, myocardial infarction, stroke and major bleeding (VARC-3 type 2 - 4)<br /><br>during one-year follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are (1) individual components of primary endpoint, (2) All<br />VARC-3 bleeding and BARC bleeding (BARC > 1), (3) rehospitalization (4) any<br />revascularization, (5) anginal status (Seattle questionnaire), (6) Canadian<br />Cardiovascular Society (CCS) and New York Heart Association (NYHA) class, (7)<br />quality of life (QoL), and (8) cost effectiveness, (9) acute kidney injury<br />(stage 3 and 4), (10) study lesion revascularization, and (11) study vessel<br />revascularization at 4 and 12 months after randomization. Furthermore, (12)<br />left ventricular function one year after randomization will be compared to<br />baseline. </p>