Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06712251
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2024-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-01-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiologic Maturation', 'timeFrame': '6 weeks', 'description': 'The proportion of participants that reach the binary outcome of Physiologic Maturation (mature/unmature). Physiologic Maturation is a composite measure, reached when Duplex ultrasound demonstrates a brachial artery blood flow of ≥ 500 ml/min and an outflow vein diameter of ≥ 5 mm.'}, {'measure': 'Serious Adverse Device Effect', 'timeFrame': '30 days', 'description': 'Any Serious Adverse Event that reasonably suggests is caused by the device or procedure'}], 'secondaryOutcomes': [{'measure': 'Functional Maturation', 'timeFrame': '3 months', 'description': 'The number of participants with successful two needle cannulation for 75% of dialysis sessions over a consecutive 4 weeks period following pAVF creation'}, {'measure': 'Unassisted Functional Maturation', 'timeFrame': '3 months', 'description': 'The number of participants that reach functional maturation without any endovascular or surgical interventions to the pAVF to facilitate maturation and/or manage complications'}, {'measure': 'Time to First Hemodialysis', 'timeFrame': 'Up to 52 weeks', 'description': 'The interval from the time of pAVF creation to the first hemodialysis session using 2-needles in the ESRD subgroup'}, {'measure': 'Number of Catheter Days', 'timeFrame': 'Up to 52 weeks', 'description': 'The number of days from pAVF creation to central venous catheter removal in the ESRD subgroup.'}, {'measure': 'Total Reinterventions', 'timeFrame': '12 months', 'description': 'All reinterventions related to the access will be captured over the life of the access until abandonment or when the subject exits the study.'}, {'measure': 'Freedom from Reintervention', 'timeFrame': 'Up to 104 weeks', 'description': 'The duration from the time of access creation until the first occurrence of a reintervention required to maintain or restore patency of the pAVF'}, {'measure': 'Technical Success', 'timeFrame': 'Day of study intervention', 'description': 'Intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein'}, {'measure': 'Primary Patency', 'timeFrame': '6 months', 'description': 'The time of access creation until the first occurrence of any reintervention to maintain or reestablish patency or until access abandonment'}, {'measure': 'Primary Assisted Patency', 'timeFrame': '6 months', 'description': 'The time from access creation to the first reintervention to maintain patency, including reinterventions intended to prevent thrombosis or restenosis, without the occurrence of thrombosis or abandonment of the access'}, {'measure': 'Cumulative Patency', 'timeFrame': '6 months', 'description': 'The interval from the time of access creation or intervention until the final abandonment of the access, inclusive of all successful interventions to maintain or restore patency'}, {'measure': 'Freedom from Serious Adverse Events', 'timeFrame': 'Up to 104 weeks', 'description': 'The time from access creation to the first occurrence of any serious adverse event (SAE)'}, {'measure': 'Functional Patency', 'timeFrame': '12 months', 'description': 'Elapsed time from functional maturation to abandonment of the access site'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Dialysis Access', 'Hemodialysis', 'AV Fistula', 'Percutaneous AVF'], 'conditions': ['Chronic Kidney Disease Requiring Hemodialysis', 'End Stage Renal Disease (ESRD)']}, 'descriptionModule': {'briefSummary': 'The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* CKD stage 4/5 or ESRD\n* Eligible for a native surgical proximal forearm radiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsor\n* Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm\n* Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm\n* Willing and competent to give written informed consent\n* Willing and able to complete all study assessments and follow-up requirements\n\nExclusion Criteria:\n\n* Distance between Proximal Radial Artery and Cubital Perforating Vein \\> 3 mm\n* Subject study extremity systolic blood pressure \\< 100mmHg Known central venous stenosis of \\> 50% ipsilateral to the study extremity\n* Any obstruction of superficial venous outflow from intended device implant site to the axillary vein\n* Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test\n* Any previous dialysis vascular access procedures in the study extremity\n* History of access related hand ischemia from a previous hemodialysis vascular access of the non-study extremity which required intervention or access abandonment\n* Upper extremity venous occlusion and/or vessel abnormality of the study extremity that precludes endovascular AVF creation as determined by principal investigator or study sponsor\n* Evidence of active systemic infections on day of the procedure or infection at the procedure access site within the past 7 days\n* History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina\n* Any contraindication to antiplatelet therapy\n* Currently being treated with another investigational device or drug\n* Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated\n* Uncontrolled or poorly controlled diabetes defined as a HbA1C \\> 10%\n* Known hypercoagulable condition, bleeding diathesis or coagulation disorder\n* Receiving anti-coagulant therapy that cannot be safely held in the peri-procedural period\n* Edema of the study extremity\n* Scheduled kidney transplant within 6 months of enrollment\n* Peripheral white blood cell count \\< 1,500 cells/microL or \\> 13,000 cells/microL and neutrophil \\> 80%\n* Platelet count \\< 75,000 cells/ microL\n* Serum procalcitonin level \\> 0.75 ng/mL for subjects with central venous catheters\n* Current diagnosis of carcinoma (unless in remission \\> 1 year)\n* Pregnant or currently breast feeding\n* History of substance abuse or anticipated to be non- compliant with medical care or study requirements based on investigator judgment\n* Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System\n* Any other medical condition that in the opinion of the investigator would put the welfare of the subject at risk or confound interpretation of the study data"}, 'identificationModule': {'nctId': 'NCT06712251', 'acronym': 'VENOS-2', 'briefTitle': 'Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access', 'organization': {'class': 'INDUSTRY', 'fullName': 'Venova Medical'}, 'officialTitle': 'Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System', 'orgStudyIdInfo': {'id': 'CP0687'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Velocity Percutaneous Arterio-Venous Fistula System', 'interventionNames': ['Device: Velocity pAVF System']}], 'interventions': [{'name': 'Velocity pAVF System', 'type': 'DEVICE', 'otherNames': ['pAVF', 'endoAVF'], 'description': 'The Velocity Percutaneous Arterio-Venous Fistula System consists of a percutaneous method designed to create an arteriovenous fistula for hemodialysis vascular access.', 'armGroupLabels': ['Velocity Percutaneous Arterio-Venous Fistula System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Trinity Research Group', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '92505', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Apex Research', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '32218', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'American Access Care of Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Research Institute', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'STAR Vascular', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Venova Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}