Arteriovenous FistulaVENOS-1NCT05757726
Early Feasibility of the Velocity™ Percutaneous PAVF System
A study testing Velocity pAVF system in people with Arteriovenous Fistula, run by Venova Medical at 1 site in Paraguay.
Trial summary
An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring hemodialysis vascular access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Velocity pAVF system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteParaguay
- Study dates
- 14 Feb 2023to 8 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosed with ESRD and currently on hemodialysis for less than 12 months using a central venous catheter for access
- Eligible for a native surgical brachiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsor
- Cubital perforating vein diameter of > 2.5 mm and length > 10.0 mm
- Proximal radial artery diameter ≥ 2.0 mm
- Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure
- Willing and competent to give written informed consent
Who cannot join
- Distance between Proximal Radial Artery and Cubital Perforating vein > 3mm
- Ipsilateral arm systolic blood pressure < 110 mmHg
- Known central venous stenosis or central vein narrowing > 50% ipsilateral to the study extremity
- Any obstruction of venous outflow from device implant site to the axillary vein
- Patients with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
- Any previous dialysis vascular access procedures in the study extremity
Show all 23Show fewer
- History of steal syndrome (hand ischemia) from a previous hemodialysis vascular access of the non-study extremity which required intervention or access abandonment
- Upper extremity venous occlusion(s) and/or vessel abnormality(ies) of the study extremity that precludes endovascular AVF creation as determined by principal investigator or study sponsor
- Evidence of active systemic infections on day of the procedure or infection at the access site within the past 7 days
- History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- Currently being treated with another investigational device or drug
- Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
- Uncontrolled or poorly controlled diabetes defined as a HbA1C > 10%
- Hypercoagulable condition, bleeding diathesis or coagulation disorder
- Receiving anti-coagulant therapy that cannot be safely held in the peri-procedural period
- Edema of the upper arm of the study extremity
- Scheduled kidney transplant within 6 months of enrollment
- Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3
- Current diagnosis of carcinoma (defined as in remission < 1 year)
- Pregnant or currently breast feeding
- History of substance abuse or anticipated to be non- compliant with medical care or study requirements based on investigator judgment
- Allergies to NiTi alloy or any of the components of the Velocity Implant or Delivery System
- Written informed consent not obtainable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring hemodialysis vascular access.
- Conditions
- Arteriovenous Fistula
- Being tested
- Velocity pAVF system
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velocity pAVF systemDevice
A second generation percutaneous AVF device that creates an AVF between the proximal radial artery and cubital perforating vein.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Not described Receives: Device: Velocity pAVF system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
Defined as Velocity deployment and delivery system withdrawal with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein 2 cm central from the pAVF anastomosis
Measured: Immediate
Serious Adverse Device Events
Defined as any Serious Adverse Event that reasonably suggests is caused by the device or procedure.
Measured: 6 weeks
Major Reintervention
Defined as any open surgery, thrombectomy or thrombolysis in the index limb following pAVF creation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start14 Feb 2023
- Primary completion15 Nov 2023
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venova Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, MD, Principal investigator, Sanatorio Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757726
- Sponsor's protocol ID
- CP0251.A
- Acronym
- VENOS-1
- Status last verified
- Oct 2024
- First submitted
- 23 Feb 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
- ClinicalTrials.gov ID
- NCT05757726
- Acronym / sponsor ID
- VENOS-1 / CP0251.A
- Conditions
- Arteriovenous Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Venova MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring hemodialysis vascular access.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Device: Velocity pAVF system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Diagnosed with ESRD and currently on hemodialysis for less than 12 months using a central venous catheter for access
- Eligible for a native surgical brachiocephalic arteriovenous fistula following assessment by the principal investigator and study sponsor
- Cubital perforating vein diameter of > 2.5 mm and length > 10.0 mm
- Proximal radial artery diameter ≥ 2.0 mm
Key exclusion criteria (23 listed)
- Distance between Proximal Radial Artery and Cubital Perforating vein > 3mm
- Ipsilateral arm systolic blood pressure < 110 mmHg
- Known central venous stenosis or central vein narrowing > 50% ipsilateral to the study extremity
- Any obstruction of venous outflow from device implant site to the axillary vein
- Patients with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Velocity pAVF systemA second generation percutaneous AVF device that creates an AVF between the proximal radial artery and cubital perforating vein. | Device | Interventional Arm |
Primary outcome
Procedural Success
Time frame: Immediate
Defined as Velocity deployment and delivery system withdrawal with intraprocedural duplex ultrasound demonstrating arterialized flow in the cephalic vein 2 cm central from the pAVF anastomosis
Serious Adverse Device Events
Time frame: 6 weeks
Defined as any Serious Adverse Event that reasonably suggests is caused by the device or procedure.
Major Reintervention
Time frame: 6 weeks
Defined as any open surgery, thrombectomy or thrombolysis in the index limb following pAVF creation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Ebner, MD principal investigator
Sanatorio Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Velocity pAVF system in people with Arteriovenous Fistula, run by Venova Medical at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success (time frame: Immediate). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.