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Early Feasibility of the Velocity™ Percutaneous pAVF System (VENOS-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05757726
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
Venova Medical

Study Description
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Brief Summary:
An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring hemodialysis vascular access.

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Device: Velocity pAVF system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
Actual Study Start Date : February 14, 2023
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventional Arm Device: Velocity pAVF system
A second generation percutaneous AVF device that creates an AVF between the proximal radial artery and cubital perforating vein.


Outcome Measures
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Primary Outcome Measures :
  1. Procedural Success [ Time Frame: Immediate ]
    Defined as Velocity deployment and delivery system withdrawal with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein 2 cm central from the pAVF anastomosis

  2. Serious Adverse Device Events [ Time Frame: 6 weeks ]
    Defined as any Serious Adverse Event that reasonably suggests is caused by the device or procedure.

  3. Major Reintervention [ Time Frame: 6 weeks ]
    Defined as any open surgery, thrombectomy or thrombolysis in the index limb following pAVF creation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosed with ESRD and currently on hemodialysis for less than 12 months using a central venous catheter for access
  • Eligible for a native surgical brachiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsor
  • Cubital perforating vein diameter of > 2.5 mm and length > 10.0 mm
  • Proximal radial artery diameter ≥ 2.0 mm
  • Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure
  • Willing and competent to give written informed consent

Exclusion Criteria:

  • Distance between Proximal Radial Artery and Cubital Perforating vein > 3mm
  • Ipsilateral arm systolic blood pressure < 110 mmHg
  • Known central venous stenosis or central vein narrowing > 50% ipsilateral to the study extremity
  • Any obstruction of venous outflow from device implant site to the axillary vein
  • Patients with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
  • Any previous dialysis vascular access procedures in the study extremity
  • History of steal syndrome (hand ischemia) from a previous hemodialysis vascular access of the non-study extremity which required intervention or access abandonment
  • Upper extremity venous occlusion(s) and/or vessel abnormality(ies) of the study extremity that precludes endovascular AVF creation as determined by principal investigator or study sponsor
  • Evidence of active systemic infections on day of the procedure or infection at the access site within the past 7 days
  • 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
  • Currently being treated with another investigational device or drug
  • Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
  • Uncontrolled or poorly controlled diabetes defined as a HbA1C > 10%
  • Hypercoagulable condition, bleeding diathesis or coagulation disorder
  • Receiving anti-coagulant therapy that cannot be safely held in the peri-procedural period
  • Edema of the upper arm of the study extremity
  • Scheduled kidney transplant within 6 months of enrollment
  • Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3
  • Current diagnosis of carcinoma (defined as in remission < 1 year)
  • Pregnant or currently breast feeding
  • History of substance abuse or anticipated to be non- compliant with medical care or study requirements based on investigator judgment
  • Allergies to NiTi alloy or any of the components of the Velocity Implant or Delivery System
  • Written informed consent not obtainable
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05757726


Contacts
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Contact: Laura Minarsch 408 242 5897 laura22@mmc-medical.com
Contact: Erik van der Burg evanderburg@venovamed.com

Locations
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Paraguay
Sanatorio Italiano Recruiting
Asunción, Paraguay
Contact: Santiago Gallo, MD         
Sponsors and Collaborators
Venova Medical
Investigators
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Principal Investigator: Adrian Ebner, MD Sanatorio Italiano
More Information
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Responsible Party: Venova Medical
ClinicalTrials.gov Identifier: NCT05757726    
Other Study ID Numbers: CP0251.A
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
 Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities