Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-31 @ 6:16 PM
Study NCT ID:
NCT06872905
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2025-03-07', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing)', 'timeFrame': '1-Year', 'description': 'Proportion of patients maintaining primary patency at 1 Year'}, {'measure': 'Primary Safety Endpoint: 30-day Morbidity (hypothesis testing)', 'timeFrame': '30-Day', 'description': 'Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention.'}], 'secondaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'At index procedure', 'description': 'Proportion of patients with technical success'}, {'measure': 'Mortality', 'timeFrame': '30-Day', 'description': 'Proportion of patients with all cause death'}, {'measure': 'Device Integrity', 'timeFrame': '1 year', 'description': 'Proportion of patients achieving Primary Patency'}, {'measure': 'Primary assisted patency', 'timeFrame': '1 year', 'description': 'Proportion of patients achieving Primary Assisted patency'}, {'measure': 'Secondary patency', 'timeFrame': '1 year', 'description': 'Proportion of patients achieving Secondary Patency'}, {'measure': 'Freedom from Target Lesion Revascularization', 'timeFrame': '1 year', 'description': 'Proportion of patients achieving freedom from Target Lesion Revascularization'}, {'measure': 'Survival', 'timeFrame': '1 Year', 'description': 'Proportion of patients survival'}, {'measure': 'Freedom from Clinically-Driven Target Lesion Revascularization', 'timeFrame': '1 year', 'description': 'Proportion of patients achieving freedom from Clinically-Driven Target Revascularization'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortoiliac Occlusive Disease']}, 'descriptionModule': {'briefSummary': 'The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).', 'detailedDescription': 'A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'As described in the background section, patients with aortoiliac occlusive disease are treated with various surgical and endovascular therapies to improve arterial blood flow to the lower extremity. This study will retrospectively evaluate a population of patients that have had covered endovascular reconstruction of the aortic bifurcation (CERAB) with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.\n\nThe study has been designed with standard eligibility criteria to evaluate the safety and effectiveness of the VBX Device when used in a CERAB for an aortoiliac occlusive disease patient population.\n\nConsidering the nature of aortoiliac occlusive disease, elderly patients (≥ 65 years old) can represent a significant number of patients enrolled in this study. This population can include patients with cognitive disorder or severe dementia.\n\nAccording to EU regulation, elderly patients are considered vulnerable population. However, considering the retrospective nature of the study design, t', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).\n2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.\n3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.\n4. Age ≥18 years at the time of CERAB procedure.\n5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -\n\nExclusion Criteria:\n\n1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.\n2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).\n3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT06872905', 'briefTitle': 'Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease', 'orgStudyIdInfo': {'id': 'VBX 24-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GORE VIABAHN® VBX Balloon Expandable Endoprosthesis', 'description': 'Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure.', 'interventionNames': ['Device: GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)']}], 'interventions': [{'name': 'GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)', 'type': 'DEVICE', 'description': 'Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.', 'armGroupLabels': ['GORE VIABAHN® VBX Balloon Expandable Endoprosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93721', 'city': 'Fresno', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Jonelle O'Shea", 'role': 'CONTACT'}, {'name': 'Laurel Hastings, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robin Stein', 'role': 'CONTACT'}, {'name': 'Linda Harris, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Research Foundation SUNY Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bridget Coyle', 'role': 'CONTACT'}, {'name': 'Ajit Rao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Subhashish Das', 'role': 'CONTACT'}, {'name': 'Kyongjune Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '24016', 'city': 'Roanoke', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yili Zhong', 'role': 'CONTACT'}, {'name': 'Esmaeel Dadashzadeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carilion Clinic', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angela Varsho', 'role': 'CONTACT'}, {'name': 'Shameem Kunhammed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Marshfield Hospital', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '35131', 'city': 'Padua', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'centralContacts': [{'name': 'Jennifer Camoriano, BS', 'role': 'CONTACT', 'email': 'jcamoria@wlgore.com', 'phone': '14805365820'}, {'name': 'Chris Timberlake, BS', 'role': 'CONTACT', 'email': 'ctimberl@wlgore.com', 'phone': '1-928-707-4974'}], 'overallOfficials': [{'name': "Leigh Ann O'Banion, M.D.", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Michele Antonello, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero-Universitaria di Padova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}