Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-02 @ 6:29 AM
Study NCT ID:
NCT03538392
Status:
WITHDRAWN
Last Update Posted:
2020-04-10
First Post:
2018-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Product not available, study withdrawn', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-05-24', 'lastUpdatePostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance', 'timeFrame': 'The registry will collect acute procedural data through hospital discharge, no additional follow up is required. Performance data will be summarized after enrollment is complete, estimated to be 1 year.', 'description': 'Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a diameter stenosis of \\<50% by visual assessment at the intended target site after using the Serranator® device.'}], 'secondaryOutcomes': [{'measure': 'Collection of device related Major Adverse Events (MAE) until discharge', 'timeFrame': 'Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first', 'description': 'Safety defined as incidence of device related MAE, defined as amputations or re-interventions (surgical or endovascular)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease', 'Arterio-venous Fistula', 'Arteriovenous Graft']}, 'descriptionModule': {'briefSummary': 'The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.', 'detailedDescription': 'Single Arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (PAD) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. The study will capture acute angiographic data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of subjects with claudication or ischemic rest pain, requiring dilatation of lesions, in the iliac or femoropopliteal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.', 'healthyVolunteers': False, 'eligibilityCriteria': '* Subject requires angioplasty\n* Subject has a lesion in the iliac, femoral, iliofemoral, popliteal artery, or obstructive lesion of native or synthetic arteriovenous dialysis fistulae as per the product indications for use'}, 'identificationModule': {'nctId': 'NCT03538392', 'briefTitle': 'Serranator® Alto Post Market Clinical Follow Up (PMCF) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cagent Vascular LLC'}, 'officialTitle': 'Post Market Clinical Follow-up Study - PMCF Study, Serranator® Alto', 'orgStudyIdInfo': {'id': 'Serranator® Alto PMCF Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PAD', 'interventionNames': ['Device: Serranator® Alto']}, {'label': 'AV Fistula', 'interventionNames': ['Device: Serranator® Alto']}, {'label': 'AV Graft', 'interventionNames': ['Device: Serranator® Alto']}], 'interventions': [{'name': 'Serranator® Alto', 'type': 'DEVICE', 'description': 'Serranator® Alto PTA Serration Balloon Catheter', 'armGroupLabels': ['AV Fistula', 'AV Graft', 'PAD']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cagent Vascular LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}