Pivotal Voyager Ark Device Vascular Access Study

Study Overview
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Brief Summary
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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.

Detailed Description
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This clinical investigation is estimated to last approximately 36-48 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 24 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

Official Title
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Pivotal Voyager Ark Device Vascular Access Study

Conditions
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Dialysis; Complications, Vascular Access Complication

Intervention / Treatment
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* Device: Ark Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AVF is uncannulatable* in upper arm or forearm per the patient's nephrologist and/or vascular access surgeon. *AVF is deemed 'uncannulatable' if at least one of the following apply: Three or more failed access attempts within six consecutive sessions The fistula cannot be palpated to locate and define its margins The fistula is only cannulatable in a segment that is too short to appropriately accommodate two needles The patient must have signed and dated the Informed Consent Form. The patient is a candidate for hemodialysis. The patient's life expectancy is ≥1 year per the Investigator. The patient's fistula diameter (AVF) at the planned site of implantation is ≥5 mm. The patient does not have clinically significant flow abnormalities with fistula flow ≥500 mL/min via ultrasound. Exclusion Criteria: The patient's AVF is a non-transposed brachial vein outflow AVF. The patient has high flow rates placing the patient at risk for heart failure and death at the discretion of the Investigator. The patient has a known skin infection, hypersensitive skin, skin breakdown/erosion or skin allergies at the potential implant sites. The patient has a known active systemic infection or positive blood cultures present. The patient's AVF has undergone a major revision and at the discretion of the Investigator can impact fistula viability and Ark device placement, such as DRIL or PTFE segment insertion, banding, aneurysm repair, etc. Patient is <18 years of age. The patient plans to become pregnant prior to their potential treatment date. The patient has a body mass index >50. Height: ___________inches Weight: _________pounds BMI: _________ kg/m2 The patient has a known clinically significant bleeding or coagulation disorder. The patient has an active malignancy. The patient has a known or suspected allergy to titanium, aluminum, or vanadium. The patient 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. The patient has had a significant peripheral vascular disease requiring a major intervention within the previous 12 months. The patient has had a significant neurovascular event such as stroke or major intervention within the previous 12 months. The patient has an uncontrolled major symptomatic medical problem per the Investigator. The patient 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. The patient is currently participating in another investigational drug or device investigation that could clinically interfere with the endpoints of this investigation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a pivotal, interventional, prospective, single arm, open-label study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ark Implantation<br>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). | Device: Ark Implantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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