Percutaneous Coronary Intervention before TAVI trial
- Conditions
- Aortic valve stenosis and coronary artery disease
- Registration Number
- NL-OMON20879
- Lead Sponsor
- ot applicable (funding by ZonMW)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 466
Inclusion Criteria
Inclusion Criteria:
1. Symptomatic severe aortic valve stenosis meeting the criteria stated by the ESC;
2. TAVI recommended by multidisciplinary Heart Team;
3. Significant coronary artery disease: = 1 stenosis in epicardial coronary artery (> 2.5mm) or bypass graft. Stenosis is considered significant if angiographic 70-99% or angiographic 40-70% with positive hemodynamic parameters
Exclusion Criteria
1. LM-stenosis or equivalent
2. CAD with patent bypass grafts
3. Contraindication for DAPT
4. Life expectancy < 1 year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method composite of all-cause mortality, myocardial infarction, stroke and major bleeding after 12 months
- Secondary Outcome Measures
Name Time Method Several at different endpoints (4-12 months, total follow up 5 years): all-cause mortality, myocardial infarction, stroke, major and minor bleeding, urgent and elective revascularization, rehospitalization, anginal status, QoL, cost-effectiveness, LV-function.