Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT07048067
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2025-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Evaluation for Baxter VASCU-GUARD Vascular Patches Post-Endarterectomy and Complications Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016894', 'term': 'Endarterectomy, Carotid'}], 'ancestors': [{'id': 'D004691', 'term': 'Endarterectomy'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-28', 'size': 1558804, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-23T14:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2025-06-24', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound evaluation of Baxter VASCU-GUARD vascular patches', 'timeFrame': '1/1/2023 - 4/30/2024', 'description': 'Retrospective review of ultrasound recordings and ultrasound reports at one-month, 3-months, 6-months and 1-year follow-up after endarterectomy - if available, to evaluate patch patency, morphology, integrity, complications, and blood flow dynamics'}], 'secondaryOutcomes': [{'measure': 'Complications assessment', 'timeFrame': '1/1/2023 - 4/30/2024', 'description': 'Analyze complications linked with Baxter Vascular Patches (VASCU-GUARD), including but not limited to thrombosis, stroke, dissection, restenosis, infection, fluid collection, pseudoaneurysm formation, fraying or irregularities in patch material.'}, {'measure': 'Correlation with Clinical Outcomes', 'timeFrame': '1/1/2023 - 4/30/2024', 'description': 'Recognize correlations between ultrasound findings and clinical outcomes. This correlation will complement the understanding of how ultrasound monitoring can predict and influence patient prognosis.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['carotid endarterectomy (CEA)', 'VASCU-GUARD'], 'conditions': ['Carotid Endarterectomy (CEA) Surgical Patients']}, 'descriptionModule': {'briefSummary': 'VASCU-GUARD vascular patches with the new packaging have been available at the Houston Methodist Hospital since January 2023. This study is a retrospective chart review, aiming to compare the performance of Baxter VASCU-GUARD vascular patches implemented during carotid endarterectomies (CEA) prior to January 2023 and after January 2023. This study is one of a kind, as no other comparative retrospective chart review on the performance of VASCU-GUARD vascular patches from the old and new packaging has been published yet.\n\nThe project will contribute to the scientific knowledge about long-term outcomes associated with the use of patch material during endarterectomies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches in all campuses of the Houston Methodist Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and above.\n* Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches.\n* Follow-up ultrasound assessment available\n\nExclusion Criteria:\n\n• No postoperative ultrasound assessment is available.'}, 'identificationModule': {'nctId': 'NCT07048067', 'acronym': 'VASCU-GUARD', 'briefTitle': 'Ultrasound Evaluation for Baxter VASCU-GUARD Vascular Patches Post-Endarterectomy and Complications Assessment', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Ultrasound Evaluation for Baxter VASCU-GUARD Vascular Patches Post-Endarterectomy and Complications Assessment', 'orgStudyIdInfo': {'id': '00038233'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches', 'description': 'Follow-up ultrasound assessment available', 'interventionNames': ['Procedure: Carotid endarterectomy (CEA)']}], 'interventions': [{'name': 'Carotid endarterectomy (CEA)', 'type': 'PROCEDURE', 'description': 'carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches', 'armGroupLabels': ['Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only study findings to be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Cardiovascular Surgery', 'investigatorFullName': 'Rahimi, Maham', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}