VasQ for Kidney Failure

Recruiting at 2 trial locations

Overseen By Galit Itzhaki

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laminate Medical Technologies

Disqualifiers: Revision surgery, Stenotic vein, Unusual anatomy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

300 Participants Needed

Trial Summary

Do I need to stop my current medications for the VasQ trial?

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 data supports the effectiveness of the treatment VasQ for kidney failure?

Research shows that the VasQ device, used in creating arteriovenous fistulas (AVFs) for hemodialysis, improves the success and function of these fistulas, which are crucial for patients with kidney failure. Studies indicate that VasQ helps stabilize blood flow and increase the maturation and usability of AVFs, suggesting it could be effective for kidney failure treatment. ^{1 2 3 4 5}

What is the purpose of this trial?

VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula

Research Team

John F Lucas III, MD, FACS, FSVS

Principal Investigator

Greenwood Leflore Hospital

Eligibility Criteria

This trial is for adults aged 18-80 with chronic kidney failure who need a new arteriovenous fistula for dialysis. Candidates must be able to attend follow-up visits over 12 months and consent to participate. Pregnant women are excluded.

Inclusion Criteria

I can attend all follow-up visits for the next 12 months.

I am a candidate for a new dialysis access surgery in my arm and agree to participate in the study.

I am a man or a woman who is not pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the VasQ supported fistula or standard of care fistula

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• VasQ

Trial Overview The study compares the use of VasQ, an external support implant, with standard care in creating arteriovenous fistulas for dialysis access. It's a randomized trial involving 300 patients divided into two groups: one receiving VasQ and the other receiving standard treatment.

Participant Groups

Group I: End to side fistula supported with VasQ Experimental Treatment 2 Interventions

Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access

Group II: Standard of care end to side fistula Active Control 1 Intervention

Patients receiving an end to side arteriovenous fistula, for fistula access

Who Is Running the Clinical Trial?

Laminate Medical Technologies

Lead Sponsor

Trials

5

Recruited

590+

Findings from Research

In a study involving 150 patients over 3 years, the VasQ™ support device significantly improved the maturation rates of radial-cephalic arteriovenous fistulas (RCAVFs), achieving a 95% maturation rate, with 89% being unassisted.

The device also demonstrated excellent patency rates, with assisted patency at 30 months being 73% and secondary patency at 84%, indicating its effectiveness in maintaining long-term vascular access for hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving high maturation and cannulation rates of radial-cephalic arteriovenous fistulas with VasQ™ device. Shahverdyan, R., Hentschel, DM.[2023]

A survey of 749 haemodialysis patients revealed that those with arteriovenous fistulas (AVF) reported significantly better quality of life scores compared to those using arteriovenous grafts (AVG) or central venous catheters (CVC).

The study found that satisfaction with vascular access improved with age and the duration of access, indicating that older patients and those with longer-term access tend to have better perceptions of their haemodialysis experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The vascular access questionnaire: a single centre UK experience. Field, M., Khawaja, AZ., Ellis, J., et al.[2020]

Networks play a crucial role in improving outcomes for patients with end-stage renal disease (ESRD) by shifting from quality assurance to continuous quality improvement, which includes developing quality improvement projects and sharing outcome measures with facilities.

While hemodialysis outcomes focus mainly on adequacy and anemia management, there are still significant opportunities for improvement in areas like peritoneal dialysis, nutrition, and quality of life, highlighting the need for tailored approaches in different facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous quality improvement in ESRD: the role of networks, the United States Renal Data System, and facility-specific reports. Goldman, RS.[2019]

In a study of 51 patients across three countries, arteriovenous fistulae (AVF) created using the VasQ external support device achieved a high maturation rate of 91% and a primary patency rate of 77% at 6, 12, and 18 months, indicating effective long-term functionality.

The study also reported an 86% successful cannulation rate for dialysis, with a median time of 46 days from AVF creation to cannulation, demonstrating the device's efficacy in facilitating timely access for patients requiring dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter European real-world utilization of VasQ anastomotic external support device for arteriovenous fistulae. Shahverdyan, R., Tabbi, P., Mestres, G.[2022]

The VasQTM device appears to stabilize the flow in arteriovenous fistulas (AVFs) for hemodialysis, maintaining the angle between the artery and vein and resulting in more stable hemodynamics compared to conventional AVFs.

In a pilot study involving six patients, the use of VasQTM showed promising results, as it prevented extreme vein dilatation and stenosis development that were observed in the control group, suggesting potential benefits for AVF maturation and longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arteriovenous fistula creation with VasQTM device: A feasibility study to reveal hemodynamic implications. Bozzetto, M., Soliveri, L., Poloni, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Achieving high maturation and cannulation rates of radial-cephalic arteriovenous fistulas with VasQ™ device. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The vascular access questionnaire: a single centre UK experience. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Continuous quality improvement in ESRD: the role of networks, the United States Renal Data System, and facility-specific reports. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Multicenter European real-world utilization of VasQ anastomotic external support device for arteriovenous fistulae. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Arteriovenous fistula creation with VasQTM device: A feasibility study to reveal hemodynamic implications. [2022]