Trials / Recruiting
RecruitingNCT07107568
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- Sponsor
- Medical University Innsbruck · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.
Detailed description
The goal of this randomized, multicenter trial is to assess the safety and efficacy of a non-invasive diagnostic strategy using photon-counting detector computed tomography (PCD-CT) for the assessment of coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR), compared to the current standard of care using invasive coronary angiography (ICA). The trial evaluates the hypothesis that a PCD-CT-guided strategy is non-inferior to routine ICA with respect to the risk of major adverse cardiovascular events (MACE) at 12 months. MACE is defined as a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding.
Conditions
- Aortic Valve Stenosis and Insufficiency
- Coronary Artery Disease(CAD)
- Transcatheter Aortic Valve Replacement (TAVR)
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Standard Invasive Coronary Angiography | Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR. |
| DIAGNOSTIC_TEST | PCD-CT-Guided Diagnostic Strategy | Participants randomized to this arm will undergo coronary artery disease (CAD) assessment using photon-counting detector computed tomography (PCD-CT). Invasive coronary angiography (ICA) will only be performed if PCD-CT shows significant CAD, defined as ≥70% diameter stenosis in vessels ≥2.5 mm or ≥50% in the left main artery. |
Timeline
- Start date
- 2025-08-14
- Primary completion
- 2029-12-31
- Completion
- 2029-12-31
- First posted
- 2025-08-06
- Last updated
- 2025-08-22
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT07107568. Inclusion in this directory is not an endorsement.