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Ark Cannulation Trial II (ACT II)

B

BioTex

Status

Not yet enrolling

Conditions

Vascular Access Complication
Dialysis; Complications

Treatments

Device: Ark

Study type

Interventional

Funder types

Industry

Identifiers

NCT05490225
Ark Cannulation Trial II

Details and patient eligibility

About

This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the Ark based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.

Full description

This clinical investigation is estimated to last approximately 48-60 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 6 weeks as the implant site heals. The patient will be monitored for 36 months after device implantation as they undergo routine dialysis. Subjects will exit the investigation after the last visit and no device-related adverse events have been identified or are being monitored

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

  1. The subject's AVF is deemed uncannulatable because:

    1. The subject's anticipated cannulation zone(s) is/are >6mm in depth from the surface of the skin to the anterior wall of the access vein as confirmed by ultrasound within 8 weeks prior to Ark implantation (each zone, Arterial/Pull and Venous/Push, shall be assessed independently of one another for Ark placement):

      • Arterial/Pull Zone: _____ mm deep
      • Venous/Push Zone: _____ mm deep

      OR

    2. The subject's dialysis unit (which includes an experienced cannulator) attests that repeated cannulation is not achievable in their clinic due to one of the following:

      • Failed access attempt in a fistula that was previously approved for cannulation, or
      • Unable to palpate the fistula such that cannulation is not possible without patient risk.
  2. The access surgeon caring for the subject attests that the Ark is likely to be at least equivalent to other methods (such as venous transposition or suction-assisted lipectomy) that could make the AVF easier to access and reduce risk of cannulation infiltrations.

  3. The subject has either a radio-cephalic, brachio-cephalic or transposed brachio-basilic fistula.

Exclusion:

  1. The subject's access vein is >15mm in depth at either cannulation zones as measured by ultrasound within 8 weeks prior to Ark implantation.

    • Arterial/Pull Zone: _____ mm in depth
    • Venous/Push Zone: _____ mm in depth Note: these values should match inclusion criteria #1
  2. Both bidimensional measurements in the subject's access vein have a diameter of <4mm, taken with a tourniquet in place or through manual compression to the outflow, as measured by ultrasound within 8 weeks prior to Ark implantation (cannulation zone specific - one zone does not affect the other's eligibility).

    • Arterial/Pull Zone: _____ mm in diameter
    • Venous/Push Zone: _____ mm in diameter
  3. The subject has an AVF flow rate of <550mL/min in the inflow artery proximal to the arterial anastomosis as measured by ultrasound within 8 weeks prior to Ark implantation.

    • AVF Flow: _____ mL/min

  4. The subject does NOT have a prescription to receive maintenance hemodialysis at least 2 times per week.

  5. The subject's life expectancy is <1 year per the Investigator.

  6. The subject does NOT have a signed and dated consent form.

  7. The AVF is a non-transposed basilic or brachial vein outflow AVF.

  8. The subject has high flow rates placing them at risk for heart failure and death at the discretion of the Investigator.

  9. The subject has a known skin infection, hypersensitive skin, skin breakdown/erosion or skin allergies at the potential implant sites.

  10. The subject has a known active systemic infection or positive blood cultures present.

  11. The subject's AVF has undergone a major revision and at the discretion of the Investigator can impact fistula viability and Ark placement (such as DRIL or PTFE segment insertion, banding, aneurysm repair, etc.), or the subject has had an occurrence of and/or intervention for AV access stenosis or thrombosis within the past month (excluded to avoid unnecessary placement into an AVF with a high likelihood of failure).

  12. The subject is <18 years of age.

  13. The subject plans to become pregnant prior to their potential treatment date.

  14. The subject has a body mass index >50kg/m2.

  15. The subject has a known clinically significant bleeding or coagulation disorder, including but not limited to low platelet count (<50,000), hypercoagulable state (e.g., antithrombin IE deficiency, antiphospholipid or anticardiolipin antibodies, Factor V Leiden, circulating Lupus anticoagulant, current, heparin-induced thrombocytopenia, protein C or S deficiency, history of recurrent deep vein thrombosis not related to AV access).

  16. The subject has an active malignancy.

  17. The subject has a known or suspected allergy to titanium, aluminum, or vanadium.

  18. The subject has had a significant cardiovascular event/intervention that makes them a poor surgical candidate such as myocardial infarction, angioplasty, or stent placement within 3 months of implantation.

  19. The subject has had a significant peripheral vascular disease requiring a major intervention within the previous 12 months.

  20. The subject has had a significant neurovascular event such as stroke or major intervention within the previous 12 months.

  21. The subject has an uncontrolled major symptomatic medical problem per the Investigator.

  22. The subject has a likelihood of poor protocol compliance due to mental incapacity, an inability to understand treatment instructions, or for any other reason in the opinion of the Investigator.

  23. The subject is currently participating in another investigational drug or device investigation that could clinically interfere with the endpoints of this investigation.

  24. The subject's conversion to home hemodialysis is anticipated at any point during their foreseeable participation in this investigation.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Ark Implantation
Experimental group
Description:
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).
Treatment:
Device: Ark

Trial contacts and locations

8

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Central trial contact

Biotex CRO

Data sourced from clinicaltrials.gov

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