Arteriovenous FistulaAVAFLEXNCT03566927
FLEX®-DCB Dialysis ACCESS Stenosis Study
A study testing FLEX Scoring Catheter with Lutonix DCB in people with Arteriovenous Fistula, run by VentureMed Group Inc. at 1 site in United States.
Trial summary
This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- FLEX Scoring Catheter with Lutonix DCB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 10 Dec 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the informed consent form.
- Arteriovenous fistula is located in the arm.
- Native AV fistula / graft was created ≥ 30 days prior to the initial procedure and has undergone at least one hemodialysis sessions.
- Venous stenosis of the AV fistula / graft with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.
- Patients with a dysfunctional or thrombosed hemodialysis access and a >50% stenosis, regardless of prior treatment (All types of lesion and access failure)
- If AV access is thrombosed, must undergo a successful thrombectomy with minimal residual thrombus.
- Intended target lesion or if a tandem lesion can be treated with ≤120 mm of DCBs in length.
Who cannot join
- Life expectancy < 9 months
- Women who are pregnant, lactating, or planning on becoming pregnant during the duration of the study.
- The hemodialysis access is located in the leg.
- Patient has more than two lesions in the access circuit.
- Patient has a secondary non-target lesion that cannot be successfully treated
- Target lesion is located central to the axillosubclavian junction.
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- Surgical revision of the access site planned.
- Recent surgical interventions of the access site.
- Known allergy or sensitivity to iodinated contrast media, that cannot be adequately managed with pre- and post-procedure medication.
- Known allergy or sensitivity to paclitaxel.
- Patients who are taking immunosuppressive therapy, or routinely taking ≥ 10 mg of prednisone per day.
- Patients who have a medical condition, in the opinion of the Investigator, that may cause the patient to be noncompliant to the protocol or confound the data.
- Patients anticipating a kidney transplant.
- Patients anticipating a conversion to peritoneal dialysis.
- The patient has a stent located in the target or secondary non-target lesion.
- Patient has an active infection in the AV access or a systemic infection.
- Known hyper-coagulable state
- Currently participating in an investigational drug, biologic, or device study.
- Previously enrolled in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dialysis Access Institute
Orangeburg, South Carolina, 29118
About this study
This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.
- Conditions
- Arteriovenous Fistula
- Being tested
- FLEX Scoring Catheter with Lutonix DCB
- Keywords
- Arteriovenous Fistula, Vascular Fistula, Scoring, Fistula, Cardiovascular Disease
- Medical subject headings
- Arteriovenous Fistula, Vascular Fistula, Fistula, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEX Scoring Catheter with Lutonix DCBCombination product
Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.
| Study group | Role | What they receive |
|---|---|---|
| FLEX Scoring Catheter plus DCB | Experimental | This is a single-arm study. All patients will be treated with the FLEX Scoring Catheter, then a standard balloon angioplasty, followed by a Lutonix® drug-coated balloon (DCB). Receives: Combination Product: FLEX Scoring Catheter with Lutonix DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Primary Patency
Target Lesion Primary Patency at 9 months defined as the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.
Measured: 9 Months
Secondary outcomes (4)
Index of Patency Function
Index of Patency Function defined as the average time between interventions.
Measured: 3, 6, 9 Months
Assess Secondary Patency
Assess Secondary Patency defined as the time interval from initial study treatment to abandonment of the vascular access circuit.
Measured: 3, 6, 9 Months
Number of Interventions
Mean cumulative interventions per subjects over study duration.
Measured: 9 Months
Percentage of Patients with Freedom from Adverse Events
Freedom from major device, procedure and treatment site-related adverse events through 30 days' 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 posted25 Jun 2018
- Study start29 May 2018
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Why it stopped: Terminated due to warning letters issued regarding paclitaxel
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT03566927
- Sponsor's protocol ID
- FLEX-DCB 0518-2
- Acronym
- AVAFLEX
- Status last verified
- Feb 2021
- First submitted
- 12 Jun 2018
- Last updated
- 17 Feb 2021
- 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 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLEX®-DCB Dialysis ACCESS Stenosis Study
- ClinicalTrials.gov ID
- NCT03566927
- Acronym / sponsor ID
- AVAFLEX / FLEX-DCB 0518-2
- Conditions
- Arteriovenous Fistula
- Keywords
- Arteriovenous Fistula, Vascular Fistula, Scoring, Fistula, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to warning letters issued regarding paclitaxel
- Enrolment
- 34 participants (actual)
- Lead sponsor
- VentureMed Group Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 25 Jun 2018 (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.
This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLEX Scoring Catheter plus DCB | Experimental | Combination Product: FLEX Scoring Catheter with Lutonix DCBThis is a single-arm study. All patients will be treated with the FLEX Scoring Catheter, then a standard balloon angioplasty, followed by a Lutonix® drug-coated balloon (DCB). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the informed consent form.
- Arteriovenous fistula is located in the arm.
- Native AV fistula / graft was created ≥ 30 days prior to the initial procedure and has undergone at least one hemodialysis sessions.
- Venous stenosis of the AV fistula / graft with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.
- Patients with a dysfunctional or thrombosed hemodialysis access and a >50% stenosis, regardless of prior treatment (All types of lesion and access failure)
Key exclusion criteria (19 listed)
- Life expectancy < 9 months
- Women who are pregnant, lactating, or planning on becoming pregnant during the duration of the study.
- The hemodialysis access is located in the leg.
- Patient has more than two lesions in the access circuit.
- Patient has a secondary non-target lesion that cannot be successfully treated
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 Scoring Catheter with Lutonix DCBTreatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB. | Combination product | FLEX Scoring Catheter plus DCB |
Primary outcome
Target Lesion Primary Patency
Time frame: 9 Months
Target Lesion Primary Patency at 9 months defined as the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.
4 secondary outcomes
Index of Patency Function
Time frame: 3, 6, 9 Months
Assess Secondary Patency
Time frame: 3, 6, 9 Months
Number of Interventions
Time frame: 9 Months
Percentage of Patients with Freedom from Adverse Events
Time frame: 1 Month
Results and safety
The study was stopped early (reason given: Terminated due to warning letters issued regarding paclitaxel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLEX Scoring Catheter with Lutonix DCB in people with Arteriovenous Fistula, run by VentureMed Group Inc. at 1 site 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 7 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: stopped early, as of the sponsor's last update on 17 Feb 2021. 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 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 was stopped early (reason given: Terminated due to warning letters issued regarding paclitaxel). Results are not available in the source record.
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 (time frame: 9 Months). 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 17 Feb 2021.