Access Cannulation Trial II (ACT II)

A Study to Evaluate the Safety and Effectiveness of Voyager's Access Device for Patients Undergoing Routine Hemodialysis (Access Cannulation Trial II)

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Access Complication; Dialysis; Complications
• Intervention / Treatment: Device: VenaSure

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Britnee Ochabski; Phone Number: 9493224050; Email: bochabski@voyagerbiomedical.com
• Study Contact Backup: Name: Supraj Amunje; Email: samunje@voyagerbiomedical.com

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Recruiting
      • Trinity Research Group
      • Principal Investigator: Jason Beaver, MD
      • Contact: Emily Ivey Director; Phone Number: 334-456-5511; Email: eivey.trinity@gmail.com
  • California
    • Riverside, California, United States, 92505
      • Recruiting
      • Apex Research
      • Principal Investigator: Dalia Dawoud, MD
      • Contact: Karina Trejo; Phone Number: 951-529-4708; Email: ktrejo@nephrologyamg.com
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Danielle Montano CRC; Phone Number: 617-525-8555; Email: dmontano2@bwh.harvard.edu
      • Principal Investigator: Mohamed Hussain, MD
  • New York
    • Hyde Park, New York, United States, 11042
      • Recruiting
      • Northwell Health
      • Contact: Yana Etkin, MD; Phone Number: (516) 233-3701; Email: yetkin@northwell.edu
      • Contact: Victoria Wairimu; Phone Number: (516) 233-3701; Email: mwairimu@northwell.edu
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Recruiting
      • MUSC Health Orangeburg
      • Principal Investigator: Mark London, MD
      • Contact: Kristen Covington; Phone Number: (803) 395-2021; Email: covingkr@musc.edu
  • Texas
    • Austin, Texas, United States, 78756
      • Recruiting
      • Cardiothoracic and Vascular Surgeons
      • Contact: Shir Yelovitch, PhD; Phone Number: 214 512-459-8753; Email: SYelovitch@ctvstexas.com
      • Principal Investigator: Adam Turley, MD
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott & White
      • Principal Investigator: Stephen Hohmann, MD
      • Contact: Rehma Shabbir; Phone Number: 214-820-1722; Email: Rehma.Shabbir@BSWHealth.org
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Fairlawn Surgery Center
      • Principal Investigator: Ryan Evans, MD
      • Contact: Aleisha Umber Director; Phone Number: 540-904-6170; Email: AUMBER@FSCMED.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ark Implantation; Single arm study. Depending on the clinical needs of the patient, the physician will decide if a single return device is needed (ex. easily cannulatable arterial pull site but the venous return access site is poorly accessible for cannulation) or two devices (both arterial pull and venous return are poorly accessible for cannulation).	Device: VenaSure; The device will be surgically implanted at the access site in subjects undergoing routine hemodialysis. The device is expected to provide a target to aid in long-term cannulation success.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.	Incidence of success for achieving clinically functional access within a 6-month timeframe from approved cannulation through the study device.	6 months
To evaluate the safety of the study device.	The assessment and occurrence of device-related, serious adverse events (SAEs) of clinical interest (infection, aneurysm, complicated seroma) during a 12- month follow-up period from initial implantation adjudicated by a Data Monitoring Committee (DMC)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate time-related parameters surrounding the study device in facilitating hemodialysis.	Cumulative duration (days) of hemodialysis catheter exposure (post device implantation), including CVC reinsertion events	12 months
To further evaluate the safety of the study device	Incidence and types of device-related complications	12 months
To further evaluate the safety of the study device	Days to successful cannulation and hemodialysis through the device	12 months
To further evaluate the safety of the study device	Vascular access interventions required to achieve the primary effectiveness endpoint	6mo from approved cannulation through the device
To further evaluate the safety of the study device	Time required to achieve the primary endpoint for all evaluable subjects.	36 months
To further evaluate the safety of the study device	(Post intervention) Functional Cumulative Patency utilizing Kaplan-Meier methodology	3 months, 6 months, 12 months
To further evaluate the safety of the study device	Initial Safety Assessment (Time Frame = 4 weeks from initial implantation) adjudicated by a Data Monitoring Committee (DMC).	4 weeks from initial implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Outcome 2	Patient Satisfaction Survey	SCRN/BSLN, 6 months, 12 months
Exploratory Outcome 3	Utilization of health care resources: health economic data analysis to be performed based on available study data for the treatment related costs (e.g. procedural costs, hospital costs, etc.)	12 months
Exploratory Outcome 1	Infiltration rate and AVF failure rate after infiltration	36 months

Collaborators and Investigators

• Sponsor: Voyager Biomedical
• Investigators: Principal Investigator: Stephen Hohmann, MD, Baylor Scott and White Health

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2027

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Access Cannulation Trial II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If data is shared after study completion it will be redacted of any PHI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No