Clinical trial NCT05490225: Access Cannulation Trial II
Official title: A Study to Evaluate the Safety and Effectiveness of Voyager's Access Device for Patients Undergoing Routine Hemodialysis (Access Cannulation Trial II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dialysis; Complications
Vascular Access Complication
Lead sponsor: Voyager Biomedical
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pivotal, interventional, prospective, single arm, open-label study.
Primary purpose: TREATMENT

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

Detailed 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 study 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

Eligibility 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 device implantation (each zone, Arterial/Pull and Venous/Push, shall be assessed independently of one another for device 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 device 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 device 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 device implantation (cannulation zone specific - one zone does not affect the other's eligibility).

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

   • 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 device 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 (in the target limb).
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.

Primary outcomes:
measure: To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.
timeFrame: 6 months
measure: To evaluate the safety of the study device.
timeFrame: 12 months
Secondary outcomes:
measure: To investigate time-related parameters surrounding the study device in facilitating hemodialysis.
timeFrame: 12 months
measure: To further evaluate the safety of the study device
timeFrame: 12 months
measure: To further evaluate the safety of the study device
timeFrame: 12 months
measure: To further evaluate the safety of the study device
timeFrame: 6mo from approved cannulation through the device
measure: To further evaluate the safety of the study device
timeFrame: 36 months
measure: To further evaluate the safety of the study device
timeFrame: 3 months, 6 months, 12 months
measure: To further evaluate the safety of the study device
timeFrame: 4 weeks from initial implantation
Other outcomes:
measure: Exploratory Outcome 1
timeFrame: 36 months
measure: Exploratory Outcome 2
timeFrame: SCRN/BSLN, 6 months, 12 months
measure: Exploratory Outcome 3
timeFrame: 12 months
Locations:
city: Dothan
country: United States
facility: Trinity Research Group
state: Alabama
city: Riverside
country: United States
facility: Apex Research
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Orangeburg
country: United States
facility: MUSC Health Orangeburg
state: South Carolina
city: Dallas
country: United States
facility: Baylor Scott & White
state: Texas
city: Roanoke
country: United States
facility: Fairlawn Surgery Center
state: Virginia
Study officials:
affiliation: Baylor Scott and White Health
name: Stephen Hohmann, MD
role: PRINCIPAL_INVESTIGATOR
References: