Pivotal Voyager Ark Device Vascular Access Study

Overview

This is a pivotal, interventional, prospective, single arm, open-label, multi-site clinical investigation intended to further evaluate the safety and efficacy of the Ark device in achieving access of arteriovenous fistulas (AVFs) to complete hemodialysis as prescribed.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2025

Detailed Description

This clinical investigation is estimated to last approximately 20 months, from initial participant enrollment until all data collection is complete on the final participant. After the patient has the Ark device implanted, they will be observed for 4-6 weeks as the implant site heals. The patient will be monitored for 6 months after device implantation as they undergo routine dialysis.

Interventions

  • Device: Ark Implantation
    • The Ark is a two-piece, porous, 3D-printed, titanium device that surrounds a segment of the access vein arising from an arterio-venous fistula. The top of the Ark has an opening designed for easy needle insertion using a standard dialysis needle. These novel features of the Ark venous access port are designed to: Create a palpable target for easier cannulation of the access vein; Provide protection of the side and back walls of the access vein from unintended puncture; Reinforce the access vein by acting as an external support; Provide a porous structure designed to integrate with surrounding tissues and reduce the chance of foreign body reaction for long-term use.

Arms, Groups and Cohorts

  • Experimental: Ark Implantation
    • Single arm study. Depending on the clinical needs of the patient, the physician will decide if a single return Ark is needed (ex. easily cannulatable arterial pull site but the venous return access site is poorly accessible for cannulation) or two Arks (both arterial pull and venous return are poorly accessible for cannulation).

Clinical Trial Outcome Measures

Primary Measures

  • Use of the Ark device to obtain arteriovenous access for hemodialysis in subjects who have an uncannulatable AVF.
    • Time Frame: 3 months
    • Successful cannulation of AVF through the Ark device and successful hemodialysis achieved within 3 months from index procedure.

Secondary Measures

  • To evaluate AVF cannulation complications while using the Ark device.
    • Time Frame: 6 months
    • The occurrence of device- or procedure-related adverse events during the 6-month follow-up period adjudicated by an independent reviewer.

Participating in This Clinical Trial

Inclusion Criteria

1. AVF is uncannulatable* in upper arm, forearm cephalic vein outflow, or previously AVF is uncannulatable* in upper arm or forearm per the patient's nephrologist and vascular access surgeon. *AVF was deemed 'uncannulatable' if the AVF was 6 to 15 mm in depth at the required Ark access site(s), and at least one of the following apply:

  • Three or more failed access attempts within six consecutive sessions – At least two infiltrations (recurrent after period of rest) that prevented dialysis – The fistula cannot be palpated to locate and define its margins – The fistula is too tortuous to be cannulated – The fistula is only cannulatable in a segment that is too short to appropriately accommodate two needles – An aneurysm exists resulting in the fistula being too short to appropriately accommodate two needles – The entire AVF is in the range of 6 mm to 15 mm in depth 2. A second vascular access surgeon, not involved with the investigation, has also evaluated the patient's eligibility and determined the AVF to be uncannulatable per the above listed inclusion criteria. 3. The patient must have signed and dated the Informed Consent Form. 4. The patient is a candidate for hemodialysis. 5. The patient's life expectancy is ≥1 year per the Investigator. 6. The patient's fistula diameter (AVF) at the planned site of implantation is ≥4 mm. 7. The patient does not have clinically significant flow abnormalities with fistula flow ≥400 mL/min. Exclusion Criteria:

1. AVF is uncannulatable* in upper arm, forearm cephalic vein outflow, or previously AVF is uncannulatable* in upper arm or forearm per the patient's nephrologist and vascular access surgeon. *AVF was deemed 'uncannulatable' if the AVF was 6 to 15 mm in depth at the required Ark access site(s), and at least one of the following apply:

  • Three or more failed access attempts within six consecutive sessions – At least two infiltrations (recurrent after period of rest) that prevented dialysis – The fistula cannot be palpated to locate and define its margins – The fistula is too tortuous to be cannulated – The fistula is only cannulatable in a segment that is too short to appropriately accommodate two needles – An aneurysm exists resulting in the fistula being too short to appropriately accommodate two needles – The entire AVF is in the range of 6 mm to 15 mm in depth 2. A second vascular access surgeon, not involved with the investigation, has also evaluated the patient's eligibility and determined the AVF to be uncannulatable per the above listed inclusion criteria. 3. The patient must have signed and dated the Informed Consent Form. 4. The patient is a candidate for hemodialysis. 5. The patient's life expectancy is ≥1 year per the Investigator. 6. The patient's fistula diameter (AVF) at the planned site of implantation is ≥4 mm. 7. The patient does not have clinically significant flow abnormalities with fistula flow ≥400 mL/min.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • BioTex, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alan Glowczwski, MD, Study Director, Voyager Biomedical, Inc
  • Overall Contact(s)
    • Britnee L Ochabski, BS, 713-741-0111, britnee.ochabski@biotexmedical.com

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