Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-01 @ 6:49 PM
Study NCT ID:
NCT05616104
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FLEX FIRST Registry Research Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000800', 'term': 'Angioplasty, Balloon'}], 'ancestors': [{'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-07', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Primary Patency Rate', 'timeFrame': '6 months post procedure', 'description': 'Defined as freedom from clinically driven target lesion re-intervention (CD-TLR) or access circuit thrombosis measured through 6-months post- procedure.'}, {'measure': 'Serious Adverse Event Rate', 'timeFrame': '1 month', 'description': 'Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 1-month post-procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Arteriovenous Fistula', 'Arteriovenous Graft', 'Fistula', 'Arterial Occlusive Diseases']}, 'descriptionModule': {'briefSummary': 'Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.', 'detailedDescription': "Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities in real-world subjects per the Institution's standard practice and at 1-, 6-, and 12-months following treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with AVF/AVG stenosis who are eligible for FLEX/Angioplasty treatment', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is ≥18 years of age.\n2. Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:\n\n * Elevated venous pressure during hemodialysis,\n * Abnormal physical findings, and\n * Unexplained decrease in delivered dialysis dose.\n3. Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.\n4. Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.\n5. Subject understands the study and is willing and able to comply with the follow-up requirements.\n\nExclusion Criteria:\n\n1. Subject has a known or suspected systemic infection.\n2. Subject has a known or suspected infection of the hemodialysis graft.\n3. Subject has an untreatable allergy to radiographic contrast material.\n4. In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment."}, 'identificationModule': {'nctId': 'NCT05616104', 'briefTitle': 'FLEX FIRST Registry Research Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'VentureMed Group Inc.'}, 'officialTitle': 'FLEX FIRST Registry Research Protocol', 'orgStudyIdInfo': {'id': 'VMG-2022-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FLEX Vessel Prep followed by angioplasty', 'description': 'Eligible subjects will be treated with the FLEX Vessel Prep system followed by balloon angioplasty.', 'interventionNames': ['Device: FLEX Vessel Prep System']}], 'interventions': [{'name': 'FLEX Vessel Prep System', 'type': 'DEVICE', 'otherNames': ['Balloon Angioplasty'], 'description': "The FLEX Vessel Prep System to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion.\n\nFollowing FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding Instructions for Use. Once advanced into the lesion, the balloon should be inflated according to the site's standard of care.", 'armGroupLabels': ['FLEX Vessel Prep followed by angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Open Access Vascular Access', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '55112', 'city': 'New Brighton', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Vascular Surgery Center', 'geoPoint': {'lat': 45.06552, 'lon': -93.20189}}, {'zip': '29118', 'city': 'Orangeburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Dialysis Access Institute', 'geoPoint': {'lat': 33.49182, 'lon': -80.85565}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Spartanburg Regional Health', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VentureMed Group Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}