Peripheral Artery DiseaseNCT04070365
FLEX Arteriovenous Access Registry
An observational study of Peripheral Artery Disease and Arteriovenous Fistula Stenosis, run by VentureMed Group Inc. at 10 sites in United States.
Trial summary
Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Arteriovenous Fistula Stenosis, Arteriovenous Graft Stenosis
- What is being tested?
- FLEX Vessel Prep System followed by angioplasty
- Type of treatment
- Medical device
- How many people
- 114 participants
- Where
- 10 sitesUnited States
- Study dates
- 28 May 2018to 26 May 2022
- 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: Patients with Arteriovenous Fistula or Arteriovenous Graft Stenosis, eligible for FLEX/Angioplasty treatment.
Who may be able to join
- Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities.
- The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form.
- The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
- The patient understands the study and is willing and able to comply with follow-up requirements.
- The patient is willing to provide informed consent.
Who cannot join
- The patient has a known or suspected systemic infection.
- The patient has a known or suspected infection of the hemodialysis graft.
- The patient has an untreatable allergy to radiographic contrast material.
- In the opinion of the operating physician, the patient's hemodialysis access is unsuitable for endovascular treatment.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
Grandview Medical Center
Birmingham, Alabama, 35243
Henry Ford Health System
Detroit, Michigan, 48202
Flowers Hospital
Dothan, Alabama, 36305
Dialysis Access Institute
Orangeburg, South Carolina, 29118
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
Richmond Vascular
Richmond, Virginia, 23235
SSM Health SLU
St Louis, Missouri, 63117
JOBST Vascular Institute
Toledo, Ohio, 43606
University of Alabama
Tuscaloosa, Alabama, 35487
About this study
Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.
- Being tested
- FLEX Vessel Prep System followed by angioplasty
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEX Vessel Prep System followed by angioplastyDevice
Also called Balloon Angioplasty
Eligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty.
| Study group | Role | What they receive |
|---|---|---|
| FLEX Vessel Prep followed by angioplasty | Not described Receives: Device: FLEX Vessel Prep System followed by angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic Success
Defined as the angiographic percentage of stenosis post procedure as <30%
Measured: At the completion of the index procedure
Secondary outcomes (7)
Technical Success of the Device
Delivery to the target lesion, deployment of the treatment element, and retrieval
Measured: At the index procedure
Clinical Success
The resumption of normal dialysis for at least one session.
Measured: 6 Months
Procedural Success
Composite of anatomic and clinical success
Measured: 6 Months
Target Lesion Primary Patency
The time interval of uninterrupted patency from initial study treatment to the next thrombosis or intervention performed on the target lesion
Measured: 6, 9 and 12 Months
Circuit Primary Patency
The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.
Measured: 6, 9, and Months
Assisted Primary Patency
The time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.
Measured: 6, 9, and 12 Months
Access Secondary Patency
The time interval from initial study treatment to abandonment of the vascular access circuit.
Measured: 6, 9, and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start28 May 2018
- Primary completion9 Jun 2021
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- VentureMed Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Aruny, MD, Principal investigator, Dialysis Access Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070365
- Sponsor's protocol ID
- AV2019
- Status last verified
- May 2022
- First submitted
- 23 Aug 2019
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLEX Arteriovenous Access Registry
- ClinicalTrials.gov ID
- NCT04070365
- Acronym / sponsor ID
- AV2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- VentureMed Group Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2018 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 28 Aug 2019 (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.
Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.
Study design
- Observational model
- Other
- 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 System followed by angioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Arteriovenous Fistula or Arteriovenous Graft Stenosis, eligible for FLEX/Angioplasty treatment.
Key inclusion criteria (5 listed)
- Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities.
- The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form.
- The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
- The patient understands the study and is willing and able to comply with follow-up requirements.
- The patient is willing to provide informed consent.
Key exclusion criteria (4 listed)
- The patient has a known or suspected systemic infection.
- The patient has a known or suspected infection of the hemodialysis graft.
- The patient has an untreatable allergy to radiographic contrast material.
- In the opinion of the operating physician, the patient'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 System followed by angioplastyAlso: Balloon AngioplastyEligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty. | Device | FLEX Vessel Prep followed by angioplasty |
Primary outcome
Anatomic Success
Time frame: At the completion of the index procedure
Defined as the angiographic percentage of stenosis post procedure as <30%
7 secondary outcomes
Technical Success of the Device
Time frame: At the index procedure
Clinical Success
Time frame: 6 Months
Procedural Success
Time frame: 6 Months
Target Lesion Primary Patency
Time frame: 6, 9 and 12 Months
Circuit Primary Patency
Time frame: 6, 9, and Months
Assisted Primary Patency
Time frame: 6, 9, and 12 Months
Access Secondary Patency
Time frame: 6, 9, and 12 Months
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 31 May 2022.
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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.
John Aruny, MD principal investigator
Dialysis Access Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease and Arteriovenous Fistula Stenosis, run by VentureMed Group Inc. at 10 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 5 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 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Anatomic Success (time frame: At the completion of the index procedure). 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 31 May 2022.