TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients with Coronary MultiVessel Disease and Aortic Valve Stenosis

TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients with Coronary MultiVessel Disease and Aortic Valve Stenosis - TCW

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50705

Enrollment

170

Registered

2017-12-19

Start date

2018-05-31

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

meervatslijden multivessel disease and aortic valve stenosis

Interventions

FFR-guided PCI and TAVI

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Symptomatic patients aged >=70 years with AS fulfilling one of these criteria (AVA =40mmHg; Aortic jet velocity >4 m/sec; or Velocity index =2 de novo coronary lesions of >=50% diameter stenosis on visual estimation located in any of main epicardial coronary arteries or side branches of a lumen caliber of more than 2 mm or single LAD lesion with more than 20 mm length or involving a bifurcation (complex), feasible for treatment with CABG as well as PCI (HT decision) 3) Patients willing and capable to provide written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients in cardiogenic shock or acute heart failure, requiring inotropic agents during procedure and/or i.v. diuretics

Design outcomes

Primary

Measure	Time frame
The primary endpoint is a composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life threatening or disabling bleeding at one year	—

Secondary

Measure	Time frame
- MACE (a composite of cardiovascular mortality, all stroke, myocardial infarction, unscheduled coronary or valve re-intervention) at one year - All-cause mortality and all stroke at 30 days and at one year	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 6, 2026