Velocity pAVF System for Kidney Failure

(VENOS-3 Trial)

Recruiting at 6 trial locations

Overseen By Shant Vartanian, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Venova Medical

Must not be taking: Antiplatelets, Investigational drugs

Disqualifiers: Severe cardiac disease, Diabetes, Carcinoma, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for creating a dialysis access point for individuals with kidney failure using the Velocity pAVF System, a medical device. Unlike traditional surgery, this approach involves a small puncture in the skin and a catheter, making it less invasive. The trial aims to evaluate the safety and effectiveness of this procedure for those requiring dialysis. It is suitable for adults needing a fistula, a special blood vessel connection, for dialysis. Participants will undergo this procedure and receive monitoring through exams and dialysis assessments for up to five years. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance dialysis access methods.

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

The trial information does not specify if 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 Velocity pAVF System is safe for creating dialysis access?

Research has shown that the Velocity Percutaneous Arteriovenous Fistula (pAVF) System aims to provide a safer and less invasive method for creating dialysis access. Early studies have focused on its safety and effectiveness, and so far, they have found no major safety issues.

The Velocity System uses a small puncture in the skin, avoiding the larger incisions required in traditional surgery. This less invasive approach is designed to speed recovery and reduce the need for additional procedures. While detailed safety information is still being collected, the technology is undergoing tests to ensure it does not cause significant device- or procedure-related problems.

For those considering participation in this study, the goal is to enhance the experience and outcomes for individuals requiring dialysis. Participation is voluntary, and the study will closely monitor safety and effectiveness to gather valuable information for future care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Velocity™ pAVF System because it offers a minimally invasive alternative to traditional surgical methods for creating dialysis access in patients with kidney failure. Unlike standard open surgery, this system uses a catheter-based procedure to create an arteriovenous fistula (AVF) through the skin, which could mean less pain and faster recovery for patients. This new approach focuses on improving the ease and safety of AVF creation, potentially enhancing long-term function and usability for hemodialysis. By reducing complications associated with open surgery, the Velocity™ pAVF System could significantly improve the quality of life for individuals requiring dialysis.

What evidence suggests that the Velocity pAVF System is effective for creating dialysis access in kidney failure patients?

Research has shown that the Velocity Percutaneous Arteriovenous Fistula (pAVF) System can create a dialysis access point without traditional surgery. In this trial, all participants will undergo the Velocity pAVF procedure, which uses a small puncture and a thin tube to form a reliable connection between an artery and a vein, essential for dialysis. This less invasive method could lead to quicker recovery and fewer complications compared to open surgery. Early evidence suggests that the Velocity System may make dialysis easier and less painful for patients. This innovation aims to provide a safer and more efficient way to prepare patients for dialysis. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults with kidney failure who need dialysis access are eligible for this trial. They should be candidates for creating an arteriovenous fistula (AVF). The study excludes individuals based on specific medical criteria not provided here.

Inclusion Criteria

Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm

Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm

Willing and able to complete all study assessments and follow-up requirements

Exclusion Criteria

Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF

My radial artery has severe calcification that affects ultrasound imaging.

Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Velocity pAVF procedure, a minimally invasive method for creating dialysis access

Immediate

1 visit (in-person)

Follow-up

Participants are monitored with physical examinations, duplex ultrasound, and dialysis assessments to evaluate fistula maturation and long-term function

5 years

Regular visits (in-person)

Long-term Monitoring

Participants are assessed for access circuit primary patency and other long-term outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Velocity™ pAVF System

Trial Overview The Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new method to create dialysis access without surgery, is being tested. Participants will have the procedure and be monitored over five years at various US centers.

How Is the Trial Designed?

Group I: Velocity pAVF System Treatment Arm Experimental Treatment 1 Intervention

Participants in this single-arm, open-label study will undergo creation of a dialysis access using the Velocity Percutaneous Arteriovenous Fistula (pAVF). The Velocity pAVF is designed to create an arteriovenous fistula (AVF) using a minimally invasive, catheter-based procedure through the skin, rather than open surgery. All subjects enrolled will receive the Velocity pAVF procedure. After the procedure, participants will be followed with physical examinations, duplex ultrasound, and dialysis assessments to evaluate fistula maturation, usability for hemodialysis, and long-term function. Additional procedures, if needed to assist maturation or maintain access function, will be recorded. Safety will be monitored throughout the study, including assessment of device-related and procedure-related complications.

Who Is Running the Clinical Trial?

Venova Medical

Lead Sponsor

Trials

2

Recruited

30+

Citations

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

NCT06712251 | Early Feasibility Study of the Velocity™ ... The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand ...

2. venovamedical.com venovamedical.com/

Venova Medical The Velocity pAVF System is the next generation of vascular access systems that will address patient level and system barriers for access creation while ...

3. 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— ...

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. innovation.ucsf.edu innovation.ucsf.edu/media/news/venova-medical-announces-first-subjects-enrolled-venos-3-pivotal-ide-study-velocityr

Venova Medical Announces First Subjects Enrolled in ... ... the safety and efficacy of the Velocity System to create a percutaneous arteriovenous (AV) fistula for hemodialysis access. More · About.