Arteriovenous Fistula StenosisNCT05034939
FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
A study testing FLEX Vessel Prep System and Angioplasty in people with Arteriovenous Fistula Stenosis, run by VentureMed Group Inc. at 7 sites in United States.
Trial summary
A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous dialysis fistulae. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arteriovenous Fistula Stenosis
- What is being tested?
- FLEX Vessel Prep System and Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Sep 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥21 years of age.
- Patient has a life expectancy of ≥12 months.
- Patient has a native AV fistula created ≥ 60 days prior to the index procedure.
- The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four-week period.
- Patient has a de novo and/or non-stented restenotic lesion located between approximately 2 cm proximal to the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis.
- Patient has a target lesion (which may include a tandem lesion) that is ≤ 100 mm in length (by visual estimate).
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- Note: Tandem lesions may be enrolled provided they meet all of the following criteria:
- Separated by a gap of ≤ 30mm (3 cm).
- Total combined lesion length, including 30 mm gap, ≤ 100 mm.
- Able to be treated as a single lesion.
- Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate)
- Patient underwent successful crossing of the target lesion with the guidewire.
- Patient provides written informed consent prior to enrollment in the study.
- Patient is willing to comply with all follow-up evaluations at specified times.
Who cannot join
- Patient is pregnant or breastfeeding.
- Patient is receiving immunosuppressive therapy.
- Patient has undergone prior intervention of access site within 30 days of index procedure.
- Patient with anticipated conversion to peritoneal dialysis.
- Patient has an infected AV access or systemic infection.
- Patient has planned surgical revision of access site.
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- Patient with secondary non-target lesion requiring treatment within 30 days post index procedure.
- Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion.
- Patient with target AVF or access circuit which previously had thrombectomy within last 30 days.
- Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.
- Patient with target lesion located central to the axillosubclavian junction.
- Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access.
- Patient has presence of pseudoaneurysm or aneurysm requiring surgical revision at the target lesion site.
- Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated.
- Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy.
- Patient with clinically significant Steal Syndrome requiring treatment.
- Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint or was previously enrolled in this study.
- Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation.
- Patient has AV fistula created via endovascular technique.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Metrolina Nephrology Associates
Charlotte, North Carolina, 28208
Dallas Nephrology Associates
Dallas, Texas, 75235
Open Access Vascular Access
Miami, Florida, 33169
Minneapolis Vascular Surgery Center
New Brighton, Minnesota, 55112
Dialysis Access Institute
Orangeburg, South Carolina, 29118
AKDHC Medical Research Services
Phoenix, Arizona, 85012
North Carolina Nephrology
Raleigh, North Carolina, 27610
About this study
Official title: FLEX Vessel Prep Prior to the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae
A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous dialysis fistulae.
Read the detailed description
This is a prospective randomized (1:1) post-market observational study evaluating the FLEX Vessel Prep System followed with PTA vs PTA alone for the treatment of de novo or non-stented restenotic obstructive lesions up to 100 mm in length located in the arteriovenous dialysis fistulae in an upper extremity.
The objective is to evaluate and compare the serious adverse event rate at 30 days and primary patency at 6 months when using FLEX Vessel Prep System prior to PTA vs. PTA alone for treatment of obstructive lesion of native arteriovenous fistulae in the upper extremity.
Enrollment will continue until complete data sets are collected for up to 75 subjects from up to 7 sites in the US.
- Conditions
- Arteriovenous Fistula Stenosis
- Being tested
- FLEX Vessel Prep System, Angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEX Vessel Prep SystemDevice
The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled depth micro-incisions.
AngioplastyDevice
The brand and type of PTA balloon(s) used will be at the discretion of the treating physician and used according to its Instructions for Use (IFU). PTA balloons consist of an over-the-wire catheter with a balloon fixed at the distal tip. Within the lesion the balloon is inflated to a pressure that allows full effacement.
| Study group | Role | What they receive |
|---|---|---|
| FLEX Vessel Prep System followed with PTA (TEST arm) | Active comparator | FLEX Vessel Prep System is used to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion. Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care. Receives: Device: FLEX Vessel Prep System |
| PTA only (CONTROL arm) | Active comparator | Standard Balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care. Receives: Device: Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Serious Adverse Event Rate
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 30 days post- procedure.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start2 Sep 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arteriovenous Fistula StenosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- VentureMed Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034939
- Sponsor's protocol ID
- VMG-2021-001
- Status last verified
- Jun 2025
- First submitted
- 27 Aug 2021
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLEX Vessel Prep Prior to the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae
- ClinicalTrials.gov ID
- NCT05034939
- Acronym / sponsor ID
- VMG-2021-001
- Conditions
- Arteriovenous Fistula Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- VentureMed Group Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous dialysis fistulae.
Detailed description
This is a prospective randomized (1:1) post-market observational study evaluating the FLEX Vessel Prep System followed with PTA vs PTA alone for the treatment of de novo or non-stented restenotic obstructive lesions up to 100 mm in length located in the arteriovenous dialysis fistulae in an upper extremity.
The objective is to evaluate and compare the serious adverse event rate at 30 days and primary patency at 6 months when using FLEX Vessel Prep System prior to PTA vs. PTA alone for treatment of obstructive lesion of native arteriovenous fistulae in the upper extremity.
Enrollment will continue until complete data sets are collected for up to 75 subjects from up to 7 sites in the US.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLEX Vessel Prep System followed with PTA (TEST arm) | Active comparator | Device: FLEX Vessel Prep SystemFLEX Vessel Prep System is used to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion. Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care. |
| PTA only (CONTROL arm) | Active comparator | Device: AngioplastyStandard Balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient is ≥21 years of age.
- Patient has a life expectancy of ≥12 months.
- Patient has a native AV fistula created ≥ 60 days prior to the index procedure.
- The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four-week period.
- Patient has a de novo and/or non-stented restenotic lesion located between approximately 2 cm proximal to the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis.
Key exclusion criteria (19 listed)
- Patient is pregnant or breastfeeding.
- Patient is receiving immunosuppressive therapy.
- Patient has undergone prior intervention of access site within 30 days of index procedure.
- Patient with anticipated conversion to peritoneal dialysis.
- Patient has an infected AV access or systemic infection.
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 |
|---|---|---|
| FLEX Vessel Prep SystemThe FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled depth micro-incisions. | Device | FLEX Vessel Prep System followed with PTA (TEST arm) |
| AngioplastyThe brand and type of PTA balloon(s) used will be at the discretion of the treating physician and used according to its Instructions for Use (IFU). PTA balloons consist of an over-the-wire catheter with a balloon fixed at the distal tip. Within the lesion the balloon is inflated to a pressure that allows full effacement. | Device | PTA only (CONTROL arm) |
Primary outcome
Primary Safety Endpoint: Serious Adverse Event Rate
Time frame: 30 Days
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 30 days post- procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLEX Vessel Prep System and Angioplasty in people with Arteriovenous Fistula Stenosis, run by VentureMed Group Inc. at 7 sites in United States.
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 14 inclusion and 19 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Safety Endpoint: Serious Adverse Event Rate (time frame: 30 Days). 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 3 Jul 2025.