Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-04 @ 4:07 PM
Study NCT ID:
NCT07107568
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "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."}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular events (MACE) at 12 months', 'timeFrame': '12 months after randomization', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality at 12 months', 'timeFrame': '12 months after randomization', 'description': 'All-cause mortality is defined as death from any cause.'}, {'measure': 'Cardiovascular mortality at 12 months', 'timeFrame': '12 months after randomization', 'description': 'Cardiovascular death is defined as any death due to proximate cardiac or vascular cause, including death during ICA, PCD-CT, or TAVR procedures.'}, {'measure': 'Nonfatal myocardial infarction at 12 months', 'timeFrame': '12 months after randomization', 'description': 'Nonfatal myocardial infarction will be defined according to the Fourth Universal Definition and the VARC-3 criteria, including periprocedural and spontaneous events.'}, {'measure': 'Nonfatal stroke at 12 months', 'timeFrame': '12 months after randomization', 'description': 'Nonfatal stroke is defined as a neurological deficit ≥24 hours caused by ischemia or intracranial bleeding, classified per VARC-3.'}, {'measure': 'Urgent revascularization at 12 months', 'timeFrame': '12 months after randomization', 'description': 'Defined as unplanned hospital admission or in-hospital acute coronary syndrome requiring revascularization during the same hospitalization.'}, {'measure': 'Bleeding events at 12 months', 'timeFrame': '12 months after randomization', 'description': 'Bleeding events will be classified according to VARC-3 bleeding definitions, types 2 to 4.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAVR-CT', 'PCD-CT', 'Severe Aortic Stenosis', 'Transcatheter Aortic Valve Replacement', 'TAVR', 'Photon-Counting Detector CT', 'Randomized Controlled Trial'], 'conditions': ['Aortic Valve Stenosis and Insufficiency', 'Coronary Artery Disease(CAD)', 'Transcatheter Aortic Valve Replacement (TAVR)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Severe aortic valve stenosis and indication for intervention according to current European Society of Cardiology (ESC) guidelines\n* TAVR candidate\n* Written informed consent\n\nExclusion Criteria:\n\n* Cardiogenic shock at presentation (e.g., emergency indication for TAVR)\n* Severe renal impairment with an estimated glomerular filtration rate of \\<30 mL/min/1.73 m²\n* Life expectancy \\<1 year due to other severe non-cardiac disease (e.g., malignancy)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07107568', 'acronym': 'TAVR-CT', 'briefTitle': 'Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial', 'orgStudyIdInfo': {'id': '1124/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCD-CT-Guided Diagnostic Strategy', 'description': '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.', 'interventionNames': ['Diagnostic Test: PCD-CT-Guided Diagnostic Strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Invasive Coronary Angiography', 'description': '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.', 'interventionNames': ['Diagnostic Test: Standard Invasive Coronary Angiography']}], 'interventions': [{'name': 'Standard Invasive Coronary Angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.', 'armGroupLabels': ['Standard Invasive Coronary Angiography']}, {'name': 'PCD-CT-Guided Diagnostic Strategy', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['PCD-CT-Guided Diagnostic Strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Sebastian J Reinstadler, MD, PhD', 'role': 'CONTACT', 'email': 'sebastian.reinstadler@tirol-kliniken.at', 'phone': '+43 512 504 25665'}], 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Sebastian J Reinstadler, MD, PhD', 'role': 'CONTACT', 'email': 'sebastian.reinstadler@tirol-kliniken.at', 'phone': '+43 512 504 25665'}, {'name': 'Ivan Lechner, MD, PhD', 'role': 'CONTACT', 'email': 'ivan.lechner@tirol-kliniken.at', 'phone': '+43 512 504 25665'}], 'overallOfficials': [{'name': 'Sebastian J Reinstadler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Innsbruck'}, {'name': 'Martin Reindl, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Innsbruck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}