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Percutaneous Coronary Intervention before TAVI trial

Percutaneous Coronary Intervention before TAVI trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20879
Enrollment
466
Registered
2021-08-04
Start date
2021-08-04
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic valve stenosis and coronary artery disease

Interventions

TAVI only

Sponsors

Not applicable (funding by ZonMW)
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. LM-stenosis or equivalent 2. CAD with patent bypass grafts 3. Contraindication for DAPT 4. Life expectancy < 1 year

Design outcomes

Primary

MeasureTime frame
composite of all-cause mortality, myocardial infarction, stroke and major bleeding after 12 months

Secondary

MeasureTime frame
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.

Contacts

Public ContactM Voskuil

UMC Utrecht

mvoskuil@umcutrecht.nl+31887556167

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)