Arterio-venous FistulaULTRAVIOLETFIMNCT07330817
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
A study testing PTA balloon in people with Arterio-venous Fistula and Stenosis of Arteriovenous Dialysis Fistula, run by Cardionovum GmbH at 1 site in Italy.
Trial summary
First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
- What is being tested?
- PTA balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2027to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients able to understand the purpose of the study, voluntarily agree to participate and signed Informed Consent form
- Patients with impaired haemodialysis access due to narrowed lesions, as indicated by contrast or ultrasound or clinical diagnosis.
- Indications for percutaneous endovascular therapy with diameter stenosis >50% and fistula's hemodynamic showing abnormalities (thrombosis in the AVF, high venous pressure, re-circulation, abnormal physical examination, decrease in dialysis efficiency, decrease in blood flow through the vascular access)
- Target lesion is a resistant de novo or restenotic lesion
- The target lesion is located in the reflux vein from the anastomotic site of arteriovenous fistula (AVF) to the distal end of the subclavian vein (excluding the anastomotic site of AVF); if there are no target lesions, they should be treated with standard angioplasty balloon before treating the target lesion.
Who cannot join
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study;
- Patients who are actively participating in another drug or device investigational study, who have not completed the primary endpoint follow-up period;
- Patients who have undergone major surgical procedures (such as open chest surgery, head surgery) within 30 days before being enrolled in the study;
- Patients who plan to undergo major surgical procedures (such as open chest surgery, head surgery) within 30 days after being enrolled in the study;
- Immature AVF (not used for dialysis; due to insufficient inner diameter, inability to ensure successful puncture, and inadequate blood flow, this access has not been used for successful dialysis);
- AVF has been implanted with a stent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
ASST Sette Laghi
Varese, 21100
Matteo Tozzi, MD, PhD, 0039 0332 393259, matteo.tozzi@me.com
About this study
Official title: ULTRAVIOLET FIM_A First-In-Man Single Arm Prospective Single Center Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
Read the detailed description
First-In-Man Single Site study to assess safety and efficacy of ultra-high pressure PTA balloon called ULTRAVIOLET UHP PTA in treating resistant stenotic lesions in arterio-venous fistula of dialysis patients.
- Being tested
- PTA balloon
- Keywords
- A-V fistula, First-In-Man, Ultra-High Pressure Balloon, PTA balloon, Resistant Stenotic Fistula
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA balloonDevice
Angioplasty of a resistant stenotic lesion in the arterio-venous fistula
| Study group | Role | What they receive |
|---|---|---|
| ULTRAVIOLET UHP PTA | Experimental | Percutaneous transluminal angioplasty with ultra-high-pressure balloon Receives: Device: PTA balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Ability to cross the lesion and fully efface the balloon, leaving no residual stenosis (<30%) evaluated by fistulography
Measured: At the end of the procedure (up to 40 minutes)
Freedom from procedure-related complications after 1 month
freedom from adverse events related to the procedure in 1 month follow up period
Measured: 1 month
Secondary outcomes (7)
Acute Device Success
successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure
Measured: At the end of the procedure (up to 40 minutes)
Clinical Success
after intervention, the function of hemodialysis access is improved, dialysis function is restored, and at least one complete dialysis session has been completed
Measured: At the end of the procedure (up to 40 minutes)
Procedural Surgery success
Once technical success has been achieved, no major adverse events (MAE) occurred during the procedure or hospitalization, including death, stroke, thrombosis, allergic reactions, or pulmonary disease
Measured: At the end of hospitalization (assessed up to 5 days)
Target Lesion Primary Patency
Primary patency rate refers to the peak systolic velocity ratio (PSVR) measured by Doppler ultrasound (DUS) ≤ 2.0, which confirms the absence of restenosis and does not require clinically driven target lesion revascularization (CD-TLR)
Measured: 1 month
Freedom from target lesion revascularization
Clinical symptoms and dialysis indicators indicate that dialysis cannot be successfully performed, and the target lesion location (confirmed by Doppler ultrasound) +/-5 mm proximal/distal requires re-intervention surgery
Measured: 1 month
Major Adverse Events (MAE)
Occurrence of major adverse events (MAE)
Measured: 1 month
Dialysis Circuit Patency
Patency of the whole patency circuit evaluated at Doppler Ultra-Sound (DUS)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterio-venous 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardionovum GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matteo Tozzi, MD, PhD, Principal investigator, Universita' Insubria, ASST Sette Laghi, Varese, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330817
- Sponsor's protocol ID
- CN-PER-001
- Acronym
- ULTRAVIOLETFIM
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ULTRAVIOLET FIM_A First-In-Man Single Arm Prospective Single Center Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
- ClinicalTrials.gov ID
- NCT07330817
- Acronym / sponsor ID
- ULTRAVIOLETFIM / CN-PER-001
- Keywords
- A-V fistula, First-In-Man, Ultra-High Pressure Balloon, PTA balloon, Resistant Stenotic Fistula
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cardionovum GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 9 Jan 2026 (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.
First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
Detailed description
First-In-Man Single Site study to assess safety and efficacy of ultra-high pressure PTA balloon called ULTRAVIOLET UHP PTA in treating resistant stenotic lesions in arterio-venous fistula of dialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ULTRAVIOLET UHP PTA | Experimental | Device: PTA balloonPercutaneous transluminal angioplasty with ultra-high-pressure balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients able to understand the purpose of the study, voluntarily agree to participate and signed Informed Consent form
- Patients with impaired haemodialysis access due to narrowed lesions, as indicated by contrast or ultrasound or clinical diagnosis.
- Indications for percutaneous endovascular therapy with diameter stenosis >50% and fistula's hemodynamic showing abnormalities (thrombosis in the AVF, high venous pressure, re-circulation, abnormal physical examination, decrease in dialysis efficiency, decrease in blood flow through the vascular access)
- Target lesion is a resistant de novo or restenotic lesion
- The target lesion is located in the reflux vein from the anastomotic site of arteriovenous fistula (AVF) to the distal end of the subclavian vein (excluding the anastomotic site of AVF); if there are no target lesions, they should be treated with standard angioplasty balloon before treating the target lesion.
Key exclusion criteria (6 listed)
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study;
- Patients who are actively participating in another drug or device investigational study, who have not completed the primary endpoint follow-up period;
- Patients who have undergone major surgical procedures (such as open chest surgery, head surgery) within 30 days before being enrolled in the study;
- Patients who plan to undergo major surgical procedures (such as open chest surgery, head surgery) within 30 days after being enrolled in the study;
- Immature AVF (not used for dialysis; due to insufficient inner diameter, inability to ensure successful puncture, and inadequate blood flow, this access has not been used for successful dialysis);
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 |
|---|---|---|
| PTA balloonAngioplasty of a resistant stenotic lesion in the arterio-venous fistula | Device | ULTRAVIOLET UHP PTA |
Primary outcome
Technical Success
Time frame: At the end of the procedure (up to 40 minutes)
Ability to cross the lesion and fully efface the balloon, leaving no residual stenosis (<30%) evaluated by fistulography
Freedom from procedure-related complications after 1 month
Time frame: 1 month
freedom from adverse events related to the procedure in 1 month follow up period
7 secondary outcomes
Acute Device Success
Time frame: At the end of the procedure (up to 40 minutes)
Clinical Success
Time frame: At the end of the procedure (up to 40 minutes)
Procedural Surgery success
Time frame: At the end of hospitalization (assessed up to 5 days)
Target Lesion Primary Patency
Time frame: 1 month
Freedom from target lesion revascularization
Time frame: 1 month
Major Adverse Events (MAE)
Time frame: 1 month
Dialysis Circuit Patency
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Matteo Tozzi, MD, PhD principal investigator
Universita' Insubria, ASST Sette Laghi, Varese, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTA balloon in people with Arterio-venous Fistula and Stenosis of Arteriovenous Dialysis Fistula, run by Cardionovum GmbH at 1 site in Italy.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Oct 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Silvestri, MSc (+393451016383, paolo.silvestri@cardionovum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: At the end of the procedure (up to 40 minutes)). The study lists 2 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 20 Oct 2026.