Trials / Recruiting
RecruitingNCT06559332
Coronary Artery Disease Assessment Strategies in TAVI Patients
Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 546 (estimated)
- Sponsor
- Insel Gruppe AG, University Hospital Bern · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
Summary
Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status. As the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit/risk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (TAVI) is unclear. The CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 3 years (primary objective) and patient reported outcome measures (secondary objective).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Risk-based CAD management | Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended. |
| DIAGNOSTIC_TEST | Invasive coronary angiography | Routine invasive coronary angiography prior to TAVI. PCI recommended for coronary diameter stenosis of ≥ 80% (visual angiographic assessment) in coronary segments with a reference vessel diameter of at least 2.5 mm. Timing of PCI at the operators' discretion. |
Timeline
- Start date
- 2025-03-11
- Primary completion
- 2030-03-31
- Completion
- 2032-03-31
- First posted
- 2024-08-19
- Last updated
- 2025-03-21
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT06559332. Inclusion in this directory is not an endorsement.