Arteriovenous FistulaNCT05616104
FLEX FIRST Registry Research Protocol
An observational study of Arteriovenous Fistula and Arteriovenous Graft, run by VentureMed Group Inc. at 4 sites in United States.
Trial summary
Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula, Arteriovenous Graft, Fistula
- What is being tested?
- FLEX Vessel Prep System
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Nov 2022to 4 Aug 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Subjects with AVF/AVG stenosis who are eligible for FLEX/Angioplasty treatment
Who may be able to join
- Subject is ≥18 years of age.
- Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:
- Elevated venous pressure during hemodialysis,
- Abnormal physical findings, and
- Unexplained decrease in delivered dialysis dose.
- Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.
- Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.
- Subject understands the study and is willing and able to comply with the follow-up requirements.
Who cannot join
- Subject has a known or suspected systemic infection.
- Subject has a known or suspected infection of the hemodialysis graft.
- Subject has an untreatable allergy to radiographic contrast material.
- In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Open Access Vascular Access
Miami, Florida, 33169
Minneapolis Vascular Surgery Center
New Brighton, Minnesota, 55112
Dialysis Access Institute
Orangeburg, South Carolina, 29118
Spartanburg Regional Health
Spartanburg, South Carolina, 29303
About this study
Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.
Read the detailed description
Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities in real-world subjects per the Institution's standard practice and at 1-, 6-, and 12-months following treatment.
- Being tested
- FLEX Vessel Prep System
- Medical subject headings
- Arteriovenous Fistula, Fistula, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEX Vessel Prep SystemDevice
Also called Balloon Angioplasty
The FLEX Vessel Prep System 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 into the lesion, the balloon should be inflated according to the site's standard of care.
| Study group | Role | What they receive |
|---|---|---|
| FLEX Vessel Prep followed by angioplasty | Eligible subjects will be treated with the FLEX Vessel Prep system followed by balloon angioplasty. Receives: Device: FLEX Vessel Prep System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Primary Patency Rate
Defined as freedom from clinically driven target lesion re-intervention (CD-TLR) or access circuit thrombosis measured through 6-months post- procedure.
Measured: 6 months post procedure
Serious Adverse Event Rate
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 1-month post-procedure.
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 posted15 Nov 2022
- Study start29 Nov 2022
- Primary completion1 Feb 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- VentureMed Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616104
- Sponsor's protocol ID
- VMG-2022-001
- Status last verified
- Aug 2025
- First submitted
- 7 Nov 2022
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kramer A, Schultz SR, Altman SD. Kinetic endovascular microincision creation prior to plain balloon angioplasty in real-world hemodialysis patients with vascular access dysfunction. J Vasc Surg. 2025 Nov;82(5):1799-1806. doi: 10.1016/j.jvs.2025.07.026. Epub 2025 Jul 23.
PubMed 40712843
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLEX FIRST Registry Research Protocol
- ClinicalTrials.gov ID
- NCT05616104
- Acronym / sponsor ID
- VMG-2022-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- VentureMed Group Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 15 Nov 2022 (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.
Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.
Detailed description
Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities in real-world subjects per the Institution's standard practice and at 1-, 6-, and 12-months following treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLEX Vessel Prep followed by angioplasty | – | Device: FLEX Vessel Prep SystemEligible subjects will be treated with the FLEX Vessel Prep system followed by balloon angioplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with AVF/AVG stenosis who are eligible for FLEX/Angioplasty treatment
Key inclusion criteria (8 listed)
- Subject is ≥18 years of age.
- Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:
- Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.
- Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.
- Subject understands the study and is willing and able to comply with the follow-up requirements.
Key exclusion criteria (4 listed)
- Subject has a known or suspected systemic infection.
- Subject has a known or suspected infection of the hemodialysis graft.
- Subject has an untreatable allergy to radiographic contrast material.
- In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.
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 SystemAlso: Balloon AngioplastyThe FLEX Vessel Prep System 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 into the lesion, the balloon should be inflated according to the site's standard of care. | Device | FLEX Vessel Prep followed by angioplasty |
Primary outcome
Target Lesion Primary Patency Rate
Time frame: 6 months post procedure
Defined as freedom from clinically driven target lesion re-intervention (CD-TLR) or access circuit thrombosis measured through 6-months post- procedure.
Serious Adverse Event Rate
Time frame: 1 month
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 1-month post-procedure.
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 7 Aug 2025.
- Derived from this study: PubMed 40712843Kramer A, Schultz SR, Altman SD. Kinetic endovascular microincision creation prior to plain balloon angioplasty in real-world hemodialysis patients with vascular access dysfunction. J Vasc Surg. 2025 Nov;82(5):1799-1806. doi: 10.1016/j.jvs.2025.07.026. Epub 2025 Jul 23.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula and Arteriovenous Graft, run by VentureMed Group Inc. at 4 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 8 inclusion and 4 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Target Lesion Primary Patency Rate (time frame: 6 months post procedure). 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?
On the ClinicalTrials.gov record for NCT05616104, which also lists 1 linked publication.
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 7 Aug 2025.