Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT06239493
Status:
SUSPENDED
Last Update Posted:
2025-05-31
First Post:
2023-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVUS-Guided Treatment for Percutaneous Vascular Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improve', 'timeFrame': 'Procedure (one visit)', 'description': 'Analyze IVUS images for improvement using manual and automated visualization'}], 'secondaryOutcomes': [{'measure': 'Procedural IVUS TIME', 'timeFrame': 'Procedure (one visit)', 'description': 'Procedural time will be recorded. IVUS time of insert and time of removal'}, {'measure': 'PROCEDURAL RADIATION DOSE', 'timeFrame': 'Procedure (one visit)', 'description': 'Radiation dose used during procedure will be recorded'}, {'measure': 'PROCEDURAL AMOUNT OF CONTRAST USED', 'timeFrame': 'Procedure (one visit)', 'description': 'Amount of contrast used during procedure will be recorded'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CAD', 'PAD', 'DVT']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to survey and improve the IVUS image quality and X-ray system interoperability by collecting Procedural Data (e.g. raw, pre- processed ultrasound and X-ray data, endpoints such as fluoroscopy time, contrast load and radiation dose, workflow details) during routine intravascular procedures to assure adherence to the high standards of quality during care delivery and promote procedural standardization.', 'detailedDescription': 'This is a prospective, multicenter, single-arm study to collect procedural data (e.g., raw, pre-processed IVUS, X-ray, and other procedural data) for image quality, workflow and interoperability assessments. Example of additional procedural endpoint data (e.g., time for fluoroscopy and IVUS, contrast load and radiation dose, workflow details, etc.) will be collected. The study will be conducted in a phased approach.\n\nSince the collection of IVUS raw data with a second non-diagnostic pullback affects procedure time, the two aspects of this study - collection of raw IVUS data and procedural data, will be separated until IVUS raw data can be collected directly from the IVUS system with no additional procedural time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All comers aged 18 and older scheduled to undergo a percutaneous vascular intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The Patient is ≥18 years of age.\n2. Patient is scheduled to undergo percutaneous vascular intervention - peripheral vascular or coronary PCI procedure.\n\nExclusion Criteria:\n\n1. Patients not meeting the instructions for use (IFU) of the respective IVUS catheters.\n2. Patients with lesions or vessel segments deemed unsafe for multiple IVUS pullbacks.\n3. Patients who are pregnant.'}, 'identificationModule': {'nctId': 'NCT06239493', 'acronym': 'IGT-PVI', 'briefTitle': 'IVUS-Guided Treatment for Percutaneous Vascular Interventions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'IVUS-Guided Treatment for Percutaneous Vascular Interventions', 'orgStudyIdInfo': {'id': '200421'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IVUS GUIDED', 'description': 'Those undergoing an already planned IVUS guided treatment for percutaneous vascular interventions', 'interventionNames': ['Diagnostic Test: IVUS Guided']}], 'interventions': [{'name': 'IVUS Guided', 'type': 'DIAGNOSTIC_TEST', 'description': 'Those already undergoing an IVUS guided percutaneous vascular intervention', 'armGroupLabels': ['IVUS GUIDED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85208', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Cardiovascular Associates', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulse Cardiovascular', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Center for Advanced Cardiac and Vascular Interventions', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cardiovascular and Vein Institute', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Healthcare System', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}], 'overallOfficials': [{'name': 'Eric Secemsky, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}