Velocity pAVF System for Kidney Failure

(VENOS-2 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Velocity™ Percutaneous Arterio-Venous Fistula System, which helps create an access point for hemodialysis, a treatment for kidney failure. Researchers aim to determine the device's safety and effectiveness. Individuals with severe chronic kidney disease or end-stage kidney disease who are suitable for a specific type of dialysis access in their arm may be a good fit for this trial. Participants must be willing to attend all study visits and follow instructions.

As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance dialysis access for future patients.

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 prior data suggests that the Velocity Percutaneous Arterio-Venous Fistula System is safe for creating hemodialysis vascular access?

Studies have shown that the Velocity Percutaneous Arterio-Venous Fistula System (Velocity pAVF System) is generally safe for creating the blood vessel access needed for dialysis. In one study, researchers linked no major harmful effects to the device. While patients experienced some side effects, none were serious or life-threatening.

Another study found that the system successfully created a connection between an artery and a vein in 32 out of 33 patients, demonstrating a high success rate of 97%. The device maintained its effectiveness for most patients over time, with success rates of 91.6% at 90 days, 89.3% at 180 days, and 86.7% at 360 days after the procedure.

These results suggest that the Velocity pAVF System is well-tolerated and effective in creating the necessary access for dialysis without causing major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Velocity™ Percutaneous Arterio-Venous Fistula System is unique because it offers a less invasive way to create a fistula for dialysis patients with kidney failure. Traditional methods usually involve surgical procedures, but this system uses a percutaneous approach, meaning it's done through the skin without large incisions. This can potentially reduce recovery time, lower the risk of complications, and improve patient comfort. Researchers are excited about this treatment because it could make life easier for patients who need regular dialysis by providing a safer and quicker way to access their bloodstream.

What evidence suggests that the Velocity pAVF System is effective for kidney failure?

Research has shown that the Velocity Percutaneous Arterio-Venous Fistula System can effectively create the necessary connections between an artery and a vein for dialysis. In one study, this system successfully created these connections in 97% of patients, with 32 out of 33 patients achieving success. This less invasive method aims to simplify the procedure and improve the overall experience for patients. The system reduces the number of extra procedures needed to maintain the connection. These early results are promising for people with kidney failure who need reliable access for dialysis. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06712251

NCT06712251 | Early Feasibility Study of the Velocity™ ... The study aims to understand clinical efficacy and initial clinical safety data of the device. Official Title. Early Feasibility Study of the Velocity™ ...

2. evtoday.com evtoday.com/news/venos-3-pivotal-study-begins-for-venovas-velocity-pavf-system

VENOS-3 Pivotal Study Begins for Venova's Velocity pAVF ... “This technology has the potential to reduce the invasiveness of the procedure, streamline access creation, and improve the patient experience— ...

3. venovamedical.com venovamedical.com/

Venova Medical The company has developed the Velocity System, a next generation percutaneous AVF technology designed to reduce the need for reinterventions to achieve fistula ...

4. trialx.com trialx.com/clinical-trials/listings/325411/pivotal-study-of-the-velocitytm-pavf-system/?&radius=50

Pivotal Study of the Velocity™ pAVF System This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis ...

5. withpower.com withpower.com/trial/phase-kidney-diseases-2025-31e46

Velocity pAVF System for Kidney Failure (VENOS-2 Trial) A percutaneous system successfully created arteriovenous fistulae (pAVFs) in 32 out of 33 patients (97% success rate), demonstrating a promising alternative to ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29275056/

The Pivotal Multicenter Trial of Ultrasound-Guided ... 0001). No major adverse events were attributed to the device. Cumulative patency was 91.6%, 89.3%, and 86.7% at 90 days, 180 days, and 360 days. Target dialysis ...