VasQ for Kidney Failure

Recruiting at 6 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests VasQ, a device that supports arteriovenous fistulas, which are connections made for dialysis in individuals with kidney failure. The goal is to determine if VasQ is more effective than the usual method of creating these connections. The trial includes two groups: one receiving the VasQ-supported fistula and the other receiving standard care. Individuals who need a new fistula for dialysis and can commit to follow-up visits over a year are suitable candidates for this study. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance dialysis care.

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 prior data suggests that the VasQ device is safe for use in arteriovenous fistulas?

Research has shown that the VasQ implant is safe for patients requiring dialysis. In a recent study, researchers found no safety issues when using VasQ to support arteriovenous fistulas, the connections between an artery and a vein used for dialysis. The implant helps maintain these connections, ensuring they remain open and functional.

Another study found that VasQ increases success rates and reduces the need for additional procedures, resulting in fewer follow-up visits to address issues. The implant also enabled patients to begin using their fistulas for dialysis more quickly.

Overall, VasQ appears well-tolerated and enhances dialysis access without introducing new safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VasQ for kidney failure because it introduces a supportive device to enhance the function of arteriovenous fistulas used in dialysis. Unlike standard treatment options that simply create a fistula for blood access, VasQ adds an external scaffold that helps maintain the fistula's shape and improve blood flow. This innovative approach aims to reduce complications and extend the life of the fistula, potentially leading to better outcomes for patients undergoing dialysis.

What evidence suggests that the VasQ device is effective for kidney failure?

Research shows that VasQ, a device used to support arteriovenous fistulas (AVFs), can maintain steady blood flow and enhance the effectiveness of these fistulas for dialysis patients. In this trial, one group of participants will receive an end-to-side arteriovenous fistula supported with VasQ. A study found that AVFs with VasQ remained open and functional better six months after creation compared to those without it. The success rate of these supported AVFs was impressive, with up to 92.5% staying open. VasQ's effectiveness was also high, with success rates between 88% and 100%, indicating improved fistula outcomes. Overall, VasQ appears to reduce the need for additional procedures and prolongs the durability of dialysis access. ^{1 6 7 8 9}

Who Is on the Research Team?

John F Lucas III, MD, FACS, FSVS

Principal Investigator

Greenwood Leflore Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. jvascsurg.org jvascsurg.org/article/S0741-5214(23)01729-9/fulltext

VasQ U.S. pivotal study demonstrates the safety and ... The primary and confirmatory effectiveness endpoint for this study was a superior primary patency for VasQ patients at 6-month post-AVF creation ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0741521423017299

VasQ U.S. pivotal study demonstrates the safety and ... Of VasQ AVFs requiring intervention, technical success (patent AVF at completion) was 92.5% (211/228), with the success rate for PTA alone at 97.7% (130/133).

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40317219/

Comparative effectiveness of arteriovenous fistulas created ... AVFs created with extravascular support maintained higher primary patency, improved functional success, and had less reinterventions than unsupported AVFs.

4. withpower.com withpower.com/trial/phase-kidney-failure-chronic-11-2024-b5307

VasQ for 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 ...

5. renalinterventions.net renalinterventions.net/physicians-around-the-world-agree-vasq-is-revolutionising-avf-outcomes/

VasQ is revolutionising AVF outcomes To date, this structural reinforcement that guides a more optimal venous remodelling has led to functional success rates ranging between 88–100% ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2949912725000224

Extravascular supported arteriovenous fistulas reduced the ... Creation of VasQ AVFs was associated with greater unassisted functional success, an overall lower maturation procedure rate, and shorter time to first use.

7. vascularspecialistonline.com vascularspecialistonline.com/advancing-dialysis-access-outcomes-with-extravascular-support-a-triangulated-clinical-research-approach/

Advancing dialysis access outcomes with extravascular ... In summary, VasQ patients experienced higher functional success rates at earlier timepoints, as well as reduced intervention rates and reduced ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31447072/

An Implanted Blood Vessel Support Device for ... The goal of this study was to evaluate the safety and efficacy of the VasQ implant, which intervenes on these mechanisms by physically supporting the surgical ...

9. ajkd.org ajkd.org/article/S0272-6386%2819%2930845-5/fulltext

An Implanted Blood Vessel Support Device for ... No safety signals were detected for the VasQ external support of brachiocephalic AVFs. Higher functional patency and vein luminal diameters were ...