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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCD-CT-Guided Diagnostic Strategy | Experimental | 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. |
|
| Standard Invasive Coronary Angiography | Active Comparator | Participants randomized to this arm will undergo routine invasive coronary angiography (ICA) as the standard of care for pre-TAVR assessment of coronary artery disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Invasive Coronary Angiography | Diagnostic Test | Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 events. All events will be adjudicated by an independent, blinded clinical events committee. | 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality at 12 months | All-cause mortality is defined as death from any cause. | 12 months after randomization |
| Cardiovascular mortality at 12 months | Cardiovascular death is defined as any death due to proximate cardiac or vascular cause, including death during ICA, PCD-CT, or TAVR procedures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian J Reinstadler, MD, PhD | Contact | +43 512 504 25665 | sebastian.reinstadler@tirol-kliniken.at | |
| Ivan Lechner, MD, PhD | Contact | +43 512 504 25665 | ivan.lechner@tirol-kliniken.at |
| Name | Affiliation | Role |
|---|---|---|
| Sebastian J Reinstadler, MD, PhD | Medical University Innsbruck | Principal Investigator |
| Martin Reindl, MD, PhD | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Recruiting | Innsbruck | 6020 | Austria |
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Randomized, controlled, multicenter, open-label, parallel-group, two-arm non-inferiority trial. Participants are assigned in a 1:1 ratio to either a PCD-CT-guided diagnostic strategy or standard invasive coronary angiography prior to TAVR evaluation.
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An independent, blinded Clinical Events Committee will adjudicate all primary and key secondary endpoints based on medical records. The committee members will not be informed of the participants' group allocation (PCD-CT vs. ICA). The statistical analysis will also be conducted by an independent statistician blinded to treatment assignment.
| PCD-CT-Guided Diagnostic Strategy | Diagnostic Test | 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. |
|
| 12 months after randomization |
| Nonfatal myocardial infarction at 12 months | Nonfatal myocardial infarction will be defined according to the Fourth Universal Definition and the VARC-3 criteria, including periprocedural and spontaneous events. | 12 months after randomization |
| Nonfatal stroke at 12 months | Nonfatal stroke is defined as a neurological deficit ≥24 hours caused by ischemia or intracranial bleeding, classified per VARC-3. | 12 months after randomization |
| Urgent revascularization at 12 months | Defined as unplanned hospital admission or in-hospital acute coronary syndrome requiring revascularization during the same hospitalization. | 12 months after randomization |
| Bleeding events at 12 months | Bleeding events will be classified according to VARC-3 bleeding definitions, types 2 to 4. | 12 months after randomization |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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