Ark Device for Vascular Access Complications

(ACT II Trial)

Recruiting at 15 trial locations

Overseen By Supraj Amunje

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BioTex, Inc.

Disqualifiers: High BMI, Active infection, Bleeding disorder, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Ark Device, designed to assist individuals with difficult-to-access blood vessels needed for dialysis. The researchers aim to determine if the device can safely and effectively facilitate connections to these blood vessels, commonly used in dialysis treatments. The trial seeks participants whose blood vessels are challenging to reach or use because they are too deep or not easily felt. Individuals whose dialysis team struggles to access their fistula might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance dialysis access for many patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Ark Device is safe for vascular access complications?

Research has shown that earlier tests of the Ark Device have been mostly positive. In one study, 11 out of 13 patients successfully used the device for their dialysis treatments, suggesting it works well for most participants in these tests.

Regarding safety, the study of the device is still ongoing, so long-term information may be limited. However, reaching this stage indicates that earlier tests did not uncover major safety problems. Serious safety issues would likely have prevented the device from progressing this far.

For those considering joining a trial, it's reassuring that such devices undergo thorough checks. Always consult with the medical team to understand the risks and benefits for your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Ark Device is unique because it addresses vascular access complications with a flexible, customizable approach. Unlike standard catheter-based treatments that can be limited by difficult-to-access sites, the Ark Device allows physicians to choose between one or two implantable devices based on the specific needs of each patient. This flexibility can potentially improve outcomes by ensuring that both the arterial and venous sites are optimally accessible for cannulation. Researchers are excited about this treatment because it offers a tailored solution that could enhance patient comfort and reduce complications associated with vascular access.

What evidence suggests that the Ark Device is effective for vascular access complications?

Research has shown that the Ark Device offers promising results for assisting hemodialysis patients with blood vessel access. In an earlier study, 11 out of 13 patients successfully had a tube inserted into their blood vessel using the Ark Device. All 11 of these patients experienced positive outcomes, indicating the device's effectiveness for them. This trial will further evaluate the Ark Device's effectiveness in patients with hard-to-reach blood vessels during hemodialysis. ^{1 2 3 4 6}

Who Is on the Research Team?

Stephen Hohmann, MD

Principal Investigator

Baylor Scott and White Health

Are You a Good Fit for This Trial?

This trial is for individuals with difficult-to-access arteriovenous fistulas (AVFs) used for hemodialysis. Candidates must have had multiple failed access attempts, AVFs that are not palpable or too tortuous, and certain measurements of the fistula as determined by ultrasound.

Inclusion Criteria

My dialysis access has failed multiple attempts at needle insertion.

The access surgeon attests that the Ark is likely to be at least equivalent to other methods that could make the AVF easier to access

I have a specific type of access for dialysis in my arm.

Exclusion Criteria

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

I do not undergo hemodialysis twice a week.

My AVF is made from my own basilic or brachial vein.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Healing

The study device is implanted and participants are observed for 6 weeks as the implant site heals

6 weeks

Initial Safety Assessment

Initial safety assessment of the study device is conducted

4 weeks

Treatment and Monitoring

Participants are monitored for 36 months after device implantation as they undergo routine dialysis

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Ark Device

Trial Overview The Ark device is being tested to see if it's safe and effective for cannulating AVFs in patients undergoing hemodialysis. This single-arm study involves participants who will all receive the Ark intervention at various clinical sites.

How Is the Trial Designed?

Group I: Ark Implantation Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

BioTex, Inc.

Lead Sponsor

Trials

10

Recruited

400+

Voyager Biomedical

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

A review of the MAUDE database revealed 1,118 complications associated with the StarClose SE vascular closure device, with the most common issues being failure to achieve hemostasis (36.6%) and inability to complete the deployment sequence (24.0%).

The types and frequencies of complications reported in the MAUDE database significantly differ from those in clinical trials, suggesting that real-world usage may present additional challenges not captured in controlled studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distribution of reported StarClose SE vascular closure device complications in the manufacturer and user facility device experience database. Johnson, DT., Durack, JC., Fidelman, N., et al.[2013]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39663664/

ACT I early feasibility study of the Voyager Ark vascular ... In the efficacy analysis, 11 of 13 treated patients demonstrated successful primary and secondary outcomes. Of the 11 treated patients who ...

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/11297298241302887?int.sj-full-text.similar-articles.1

ACT I early feasibility study of the Voyager Ark vascular ... Out of the 13 patients, 11 successfully experienced the primary outcome of effective initial cannulation through the Ark. The two patients who ...

3. withpower.com withpower.com/trial/phase-dialysis-complications-4-2023-ebd36

Ark Device for Vascular Access Complications (ACT II Trial) A review of the MAUDE database revealed 1,118 complications associated with the StarClose SE vascular closure device, with the most common issues being failure ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05490225

Study Details | NCT05490225 | Access Cannulation Trial II To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis. Incidence of success for ...

5. researchgate.net researchgate.net/publication/386953961_ACT_I_early_feasibility_study_of_the_Voyager_Ark_vascular_access_device

ACT I early feasibility study of the Voyager Ark vascular ... Of the 11 treated patients who initiated cannulation through the Arks, 100% experienced successful primary and secondary outcomes. None of the patients ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0741521421021820

Percutaneous arteriovenous fistula creation with the 4F ... All-cause death occurred in 5 of the 120 patients through completion of 6-month follow-up, accounting for a KM survival estimate of 93.8% ± 2.5% through 6 ...