Status
Conditions
Treatments
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
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion:
The subject's AVF is deemed uncannulatable because:
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):
OR
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:
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.
The subject has either a radio-cephalic, brachio-cephalic or transposed brachio-basilic fistula.
Exclusion:
The subject's access vein is >15mm in depth at either cannulation zones as measured by ultrasound within 8 weeks prior to Ark implantation.
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).
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
The subject does NOT have a prescription to receive maintenance hemodialysis at least 2 times per week.
The subject's life expectancy is <1 year per the Investigator.
The subject does NOT have a signed and dated consent form.
The AVF is a non-transposed basilic or brachial vein outflow AVF.
The subject has high flow rates placing them at risk for heart failure and death at the discretion of the Investigator.
The subject has a known skin infection, hypersensitive skin, skin breakdown/erosion or skin allergies at the potential implant sites.
The subject has a known active systemic infection or positive blood cultures present.
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).
The subject is <18 years of age.
The subject plans to become pregnant prior to their potential treatment date.
The subject has a body mass index >50kg/m2.
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).
The subject has an active malignancy.
The subject has a known or suspected allergy to titanium, aluminum, or vanadium.
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.
The subject has had a significant peripheral vascular disease requiring a major intervention within the previous 12 months.
The subject has had a significant neurovascular event such as stroke or major intervention within the previous 12 months.
The subject has an uncontrolled major symptomatic medical problem per the Investigator.
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.
The subject is currently participating in another investigational drug or device investigation that could clinically interfere with the endpoints of this investigation.
The subject's conversion to home hemodialysis is anticipated at any point during their foreseeable participation in this investigation.
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
Loading...
Central trial contact
Biotex CRO
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal