Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT04627051
Status:
UNKNOWN
Last Update Posted:
2021-03-12
First Post:
2020-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017073', 'term': 'Atherectomy'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Treatment of Jetstream™ atherectomy device and Ranger ™ drug coated balloons'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Primary Patency (TLPP) through 6 months', 'timeFrame': 'within 6 months post intervention', 'description': '50% re-stenosis of the target lesion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysfunctional Arterial-venous Grafts']}, 'descriptionModule': {'briefSummary': 'This single-centre, single-arm, prospective study will enroll 30 subjects presenting with clinical and hemodynamic abnormalities in arteriovenous graft (AVG) in the arm. Subjects will be treated with the Jetstream™ atherectomy device and Ranger™ Drug Coated Balloons (DCB). Subjects will be followed up clinically via office visit or phone visit at 6 and 12 months post procedure. This study is to demonstrate safety and assess the clinical use and outcomes of the Jetstream ™atherectomy device and Ranger™ DCB for the treatment of dysfunctional AV graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant, non-breastfeeding female ≥18 years of age;\n* Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;\n* Target lesion must be a mature arteriovenous graft presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines;\n* Subject has a target lesion at the venous anastomosis of the AVG;\n* Successful crossing of the stenosis;\n* Each lesion length is ≤20mm, which may include tandem lesions that are ≤20mm apart\n\nExclusion Criteria:\n\n* Subject is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this study;\n* Subject has a non-controllable allergy to contrast;\n* Subject has more than 3 lesions in the access circuit requiring intervention;\n* Target lesion diameter \\>10mm;\n* A thrombosed access or an access with a thrombosis treated ≤30 days prior to the index procedure;\n* Prior surgical interventions of the access site ≤30 days before the index procedure;\n* Target lesion is located within a bare metal or covered stent.'}, 'identificationModule': {'nctId': 'NCT04627051', 'briefTitle': 'Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Prospective, Single-Centre Study Investigating the Clinical Use and Safety of the Jetstream Atherectomy With Drug Coated Balloon (Ranger) for the Treatment of Dysfunctional Arterio-Venous Graft Stenosis', 'orgStudyIdInfo': {'id': '20-5673'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dysfunction AV graft', 'description': 'Dysfunctional AV graft stenosis treated with atherectomy and drug coated balloon angioplasty', 'interventionNames': ['Device: Atherectomy and balloon angioplasty']}], 'interventions': [{'name': 'Atherectomy and balloon angioplasty', 'type': 'DEVICE', 'description': 'Atherectomy and balloon angioplasty of arterial-venous graft stenosis', 'armGroupLabels': ['Dysfunction AV graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Kong Teng Tan, MD', 'role': 'CONTACT', 'email': 'kongteng.tan@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '6166'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}