Velocity pAVF System for Kidney Failure

(VENOS-2 Trial)

Recruiting at 4 trial locations

Overseen By Shant Vartanian, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Venova Medical

Must not be taking: Anticoagulants, Antiplatelets, others

Disqualifiers: Severe cardiac disease, Diabetes, Infections, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anti-coagulant therapy, it may need to be safely paused around the time of the procedure.

What data supports the effectiveness of the Velocity™ Percutaneous Arterio-Venous Fistula System treatment for kidney failure?

Research shows that creating arteriovenous fistulae (AVFs) using a percutaneous system, like the Velocity™ system, is feasible and can provide effective access for hemodialysis, which is crucial for patients with kidney failure. Studies comparing percutaneous AVFs to traditional surgical methods suggest that the percutaneous approach may offer similar or improved outcomes in terms of safety and efficacy. ^{1 2 3 4 5}

Is the Velocity pAVF System safe for humans?

Research on percutaneous arteriovenous fistula (pAVF) systems, like the Velocity pAVF System, shows they are generally safe for creating access for hemodialysis in patients with kidney failure. However, there can be changes in heart function, so it's important to discuss potential risks with your doctor. ^{2 5 6 7 8}

How is the Velocity pAVF System treatment different from other treatments for kidney failure?

The Velocity pAVF System is unique because it creates an arteriovenous fistula (a connection between an artery and a vein) using a minimally invasive percutaneous (through the skin) method, unlike traditional surgical techniques. This approach may offer improved short- and long-term outcomes for hemodialysis access. ^{2 4 5 8 9}

What is the purpose of this trial?

The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.

Eligibility Criteria

This trial is for adults with advanced kidney disease (stage 4/5 or end-stage renal disease) who need a new way to access their blood vessels for hemodialysis. They must have specific artery and vein sizes, be able to consent, and commit to study requirements. Those not suitable for traditional fistula surgery are excluded.

Inclusion Criteria

My radial artery is between 2.0 and 4.0 mm wide.

I am willing and able to sign the consent form.

I am willing and able to follow all study requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo the procedure to create a percutaneous arterio-venous fistula using the Velocity system

Day of study intervention

1 visit (in-person)

Initial Follow-up

Participants are monitored for physiologic maturation and any serious adverse device effects

6 weeks

Multiple visits (in-person)

Extended Follow-up

Participants are monitored for functional maturation and patency outcomes

3 to 12 months

Long-term Follow-up

Participants are monitored for long-term patency and freedom from reintervention or serious adverse events

Up to 104 weeks

Treatment Details

Interventions

• Velocity™ Percutaneous Arterio-Venous Fistula System

Trial Overview The Velocity pAVF System, a minimally invasive device designed to create an arteriovenous fistula (a connection between an artery and vein), is being tested for safety and effectiveness in providing vascular access for hemodialysis patients.

Participant Groups

Group I: Velocity Percutaneous Arterio-Venous Fistula System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Venova Medical

Lead Sponsor

Trials

2

Recruited

30+

Findings from Research

In a study of 60 end-stage renal disease patients, both Side to Side (STS) and End to Side (ETS) methods for creating arteriovenous fistulas (AVFs) showed similar functional patency rates over a 6-month follow-up period, with a total failure rate of 18.3%.

While there were slightly more non-functional AVFs in the STS group (20%) compared to the ETS group (16.6%), the differences were not statistically significant, suggesting that both techniques are equally effective for vascular access in hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of efficacy of side to side versus end to side arteriovenous fistulae formation in chronic renal failure as a permanent hemodialysis access. Mozaffar, M., Fallah, M., Lotfollahzadeh, S., et al.[2021]

A percutaneous system successfully created arteriovenous fistulae (pAVFs) in 32 out of 33 patients (97% success rate), demonstrating a promising alternative to traditional surgical methods for hemodialysis access.

At 6 months, the cumulative patency rate of pAVFs was 96.2%, with a mean maturation time of 58 days, indicating that pAVFs may offer better long-term outcomes compared to conventional surgical fistulae.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous creation of an arteriovenous fistula for hemodialysis access. Rajan, DK., Ebner, A., Desai, SB., et al.[2015]

A study of 54 primary arteriovenous fistulae (pAVFs) revealed that 54% had significant hemodynamic abnormalities detected by color duplex ultrasound (CDU) within 4 to 12 weeks post-surgery, indicating a high prevalence of critical stenoses that could affect their function.

CDU demonstrated high sensitivity (93%) and specificity (94%) in identifying stenoses of 50% or greater, suggesting that routine CDU surveillance could help detect and address issues early, potentially improving the long-term success of pAVFs in hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of critical stenosis in primary arteriovenous fistulae before hemodialysis access: should duplex ultrasound surveillance be the standard of care? Grogan, J., Castilla, M., Lozanski, L., et al.[2016]

In a study comparing 51 patients with percutaneous arteriovenous fistula (pAVF) to 51 with surgical AVF (sAVF), procedural success rates were very high for pAVF at 98%, indicating its efficacy as a viable alternative to sAVF.

While the maturation rates for pAVF (72%) and sAVF (57%) were similar, pAVF required more interventions for maturation, suggesting that while effective, pAVF may involve a more intensive follow-up process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early clinical experience and comparison between percutaneous and surgical arteriovenous fistula. Habib, SG., Jano, A., Ali, AA., et al.[2023]

In a review of 18 studies involving 1863 patients, percutaneous endovascular arteriovenous fistula (pAVF) showed promising short-term and mid-term safety and efficacy, with primary patency rates of 54.01% and secondary patency rates of 87.27%.

While pAVF did not show statistically significant differences in primary and secondary patency compared to surgical AVF (sAVF), it had a lower risk of complications like steal syndrome and wound infections, suggesting it may be a safer alternative in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review aggregated data and individual participant data meta-analysis of percutaneous endovascular arteriovenous fistula. Bontinis, A., Bontinis, V., Koutsoumpelis, A., et al.[2023]

The creation of an arteriovenous fistula (AVF) is essential for effective chronic hemodialysis but can lead to significant cardiovascular changes, potentially resulting in heart failure.

Even after successful kidney transplantation, many patients keep their AVF, which may continue to negatively impact their cardiovascular health, suggesting a need for careful management of AVFs in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Arteriovenous Fistulae for Hemodialysis on the Cardiovascular System. Rao, NN., Dundon, BK., Worthley, MI., et al.[2018]

The endovascular creation of arteriovenous fistulas (endoAVF) shows a high technical success rate of 98% and a maturation rate of 87%, indicating it is an effective option for patients with renal failure based on a systematic review of 19 studies involving 1,929 patients.

The safety profile of endoAVF is comparable to traditional surgical methods, with a complication rate of 7%, but further randomized controlled trials are needed to strengthen the evidence for clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous endovascular arteriovenous fistula: A systematic review and meta-analysis. Sun, JB., Liu, CC., Shen, X., et al.[2022]

The creation of percutaneous arteriovenous fistulas (pAVFs) using the WavelinQ 4-F EndoAVF System showed a 100% technical success rate and an 86.7% cannulation rate in a study of 30 patients, indicating high efficacy for patients needing hemodialysis.

The procedure had a low adverse event rate of 6.7%, with long-term patency rates of 96% at 1 year and 82% at 2 and 3 years, suggesting that pAVF creation is a safe and effective option for vascular access in hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Arteriovenous Fistula Creation with the WavelinQ 4-French EndoAVF System: A Single-Center Retrospective Analysis of 30 Patients. Kitrou, PM., Balta, L., Papachristou, E., et al.[2022]

The successful creation of an Ellipsys-percutaneous arteriovenous fistula (pAVF) in a 72-year-old female patient with a history of a Scribner-shunt demonstrates its feasibility for hemodialysis, with a quick procedure time of just 12 minutes.

This pAVF procedure allows for immediate use in hemodialysis and minimizes risks associated with high-flow arteriovenous fistulas, making it a safer option for patients with conditions like cardiomyopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The past and the future of vascular access surgery: Creation of percutaneous arteriovenous fistula using Ellipsys vascular access system in a patient with previous ipsilateral Scribner-shunt. Shahverdyan, R., Konner, K., Matoussevitch, V.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of efficacy of side to side versus end to side arteriovenous fistulae formation in chronic renal failure as a permanent hemodialysis access. [2021]

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

Percutaneous creation of an arteriovenous fistula for hemodialysis access. [2015]

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

Frequency of critical stenosis in primary arteriovenous fistulae before hemodialysis access: should duplex ultrasound surveillance be the standard of care? [2016]

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

Early clinical experience and comparison between percutaneous and surgical arteriovenous fistula. [2023]

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

A systematic review aggregated data and individual participant data meta-analysis of percutaneous endovascular arteriovenous fistula. [2023]

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

The Impact of Arteriovenous Fistulae for Hemodialysis on the Cardiovascular System. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Percutaneous endovascular arteriovenous fistula: A systematic review and meta-analysis. [2022]

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

Percutaneous Arteriovenous Fistula Creation with the WavelinQ 4-French EndoAVF System: A Single-Center Retrospective Analysis of 30 Patients. [2022]

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

The past and the future of vascular access surgery: Creation of percutaneous arteriovenous fistula using Ellipsys vascular access system in a patient with previous ipsilateral Scribner-shunt. [2022]