Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)B3AVNCT02408822
Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)
A study testing PTA Balloon dilatation catheter Advance® (Cook® Medical) and Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX® in people with Dysfunction of Hemodialysis Vascular Access (Fistula and Graft), run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial summary
Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)
- What is being tested?
- PTA Balloon dilatation catheter Advance® (Cook® Medical) and Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Sep 2015to 15 Jun 2026
- 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
- Patient must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female.
- Patient must have a vascular access for hemodialysis (type: brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft)
- Patient must have a dysfunction of its vascular access, defined by :
- dialysis sessions last >4 hours
- and/or access flow < 400ml/min for fistulae and <600ml for grafts, or 20% decrease in access flow as monitored during dialysis or by Duplex ultrasound scan,
- and/or dialysis recirculation
Show all 11Show fewer
- and/or thrill not perceived
- and/or pulsatile vascular access
- and/or bleeding or increased bleeding time after puncture
- A stenosis >50% of the venous line must be diagnosed on the initial fistulogram
- A successful plain balloon angioplasty of the stenosis, defined by residual stenosis <30% on control angiogram, without dissection or indication for use of stent or additional surgical procedure, must be completed before inclusion.
Who cannot join
- Pregnant or nursing woman, or plans to become pregnant during the study.
- Patient has hyperkalemia >6,5 mmol/L with EKG modifications or acute cardiac insufficiency at the time of inclusion
- Vascular access has in-stent restenosis
- Initial fistulogram shows no stenosis
- Initial fistulogram shows indication for open surgical intervention
- Control fistulogram (after plain balloon angioplasty) shows indication for stenting or open surgical intervention
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Nice - Service de chirurgie vasculaire
Nice
Clinique St Georges
Nice
CHU de Reims
Reims
About this study
Official title: Superiority of Drug-eluting Balloon Angioplasty Versus Plain Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis : a Multicentre, Randomized, Controlled Trial
Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease.
This randomized controlled trial is designed to prove the superiority of a drug-eluting balloon catheter (Paclitaxel-coated balloon) over a plain balloon catheter in the treatment of stenosed autogeneous and prosthetic vascular accesses, in hemodialysis patients.
The hypothesis is that use of drug-eluting balloon will improve post-interventional patency of the access, and therefore, limit numbers and days of hospitalization for maintenance of hemodialysis vascular accesses.
Read the detailed description
Introduction:
Half of patients with hemodialysis vascular access will present at least one episode of dysfunction within 1 year after creation, mainly due to intimal hyperplasia and stenosis. Paclitaxel is an antiproliferative drug that can limit intimal hyperplasia in vessels. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease.
Main objective:
To show that the use of Paclitaxel-coated balloons to treat stenosis of vascular accesses will improve post-interventional patency and reduce numbers and days of hospitalization for access maintenance in hemodialysis vascular access.
Hypothesis:
Paclitaxel-coated balloon angioplasty (PTX) prolongs primary patency of the access after treatment of vascular access stenosis compared to plain balloon angioplasty (PBA)(standard treatment).
Methodology:
We designed a prospective, single-blinded, multicenter, randomized, controlled trial, which aim to enroll 120 patients.
Patients diagnosed with a stenosis on their dysfunctional vascular access line (brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft) will be randomized to either arm of the study after completion of a successful pre-dilation with a standard plain balloon catheter.
Randomization will be stratified according to type of access (brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft).
Primary outcome measure will be primary patency of the vascular access at 12 months after treatment. Secondary outcome measures will be primary patency at 6 months, assisted-primary and secondary patencies at 6 and 12 months, number of re-interventions and number of days of hospitalization for re-intervention at 12 months.
Clinical significance:
By prolonging the vascular access lifespan, Paclitaxel-coated balloon angioplasty can limit morbidity and cost of vascular access maintenance for hemodialysis patients.
- Being tested
- PTA Balloon dilatation catheter Advance® (Cook® Medical), Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA Balloon dilatation catheter Advance® (Cook® Medical)Device
2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure
Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®Device
2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure
| Study group | Role | What they receive |
|---|---|---|
| PBA (Plain Balloon Angioplasty) | Active comparator | Patient receiving endovascular treatment of a vascular access stenosis by plain balloon angioplasty (mechanical action, without drug)
2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure Receives: Device: PTA Balloon dilatation catheter Advance® (Cook® Medical) |
| PTX | Experimental | (PacliTaXel-coated balloon angioplasty) Patient receiving endovascular treatment of a vascular access stenosis by drug-eluting balloon angioplasty (mechanical action + antiproliferative drug - Paclitaxel) 2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure Receives: Device: Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon
Measured: at 12 months
Secondary outcomes (5)
Primary patency of the vascular access
Measured: at 6 months after treatment
Assisted-primary patency of the vascular access
Measured: at 6 and 12 months after treatment
Secondary patency of the vascular access
Measured: at 6 and 12 months after treatment
Number of reinterventions (endovascular or surgery)
Measured: after treatment during the follow-up (at 12 months)
Days of hospitalization for reinterventions (endovascular or surgery)
Measured: after treatment during the follow-up (at 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study start29 Sep 2015
- Primary completion15 Jun 2020
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- REDA HASSEN-KHODJA, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408822
- Sponsor's protocol ID
- 15-AOI-03
- Acronym
- B3AV
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2015
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superiority of Drug-eluting Balloon Angioplasty Versus Plain Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis : a Multicentre, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02408822
- Acronym / sponsor ID
- B3AV / 15-AOI-03
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 29 Sep 2015 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 6 Apr 2015 (estimated)
- 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.
Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease.
This randomized controlled trial is designed to prove the superiority of a drug-eluting balloon catheter (Paclitaxel-coated balloon) over a plain balloon catheter in the treatment of stenosed autogeneous and prosthetic vascular accesses, in hemodialysis patients.
The hypothesis is that use of drug-eluting balloon will improve post-interventional patency of the access, and therefore, limit numbers and days of hospitalization for maintenance of hemodialysis vascular accesses.
Detailed description
Introduction:
Half of patients with hemodialysis vascular access will present at least one episode of dysfunction within 1 year after creation, mainly due to intimal hyperplasia and stenosis. Paclitaxel is an antiproliferative drug that can limit intimal hyperplasia in vessels. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease.
Main objective:
To show that the use of Paclitaxel-coated balloons to treat stenosis of vascular accesses will improve post-interventional patency and reduce numbers and days of hospitalization for access maintenance in hemodialysis vascular access.
Hypothesis:
Paclitaxel-coated balloon angioplasty (PTX) prolongs primary patency of the access after treatment of vascular access stenosis compared to plain balloon angioplasty (PBA)(standard treatment).
Methodology:
We designed a prospective, single-blinded, multicenter, randomized, controlled trial, which aim to enroll 120 patients.
Patients diagnosed with a stenosis on their dysfunctional vascular access line (brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft) will be randomized to either arm of the study after completion of a successful pre-dilation with a standard plain balloon catheter.
Randomization will be stratified according to type of access (brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft).
Primary outcome measure will be primary patency of the vascular access at 12 months after treatment. Secondary outcome measures will be primary patency at 6 months, assisted-primary and secondary patencies at 6 and 12 months, number of re-interventions and number of days of hospitalization for re-intervention at 12 months.
Clinical significance:
By prolonging the vascular access lifespan, Paclitaxel-coated balloon angioplasty can limit morbidity and cost of vascular access maintenance for hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBA (Plain Balloon Angioplasty) | Active comparator | Device: PTA Balloon dilatation catheter Advance® (Cook® Medical)Patient receiving endovascular treatment of a vascular access stenosis by plain balloon angioplasty (mechanical action, without drug) 2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure |
| PTX | Experimental | Device: Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®(PacliTaXel-coated balloon angioplasty) Patient receiving endovascular treatment of a vascular access stenosis by drug-eluting balloon angioplasty (mechanical action + antiproliferative drug - Paclitaxel) 2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female.
- Patient must have a vascular access for hemodialysis (type: brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft)
- Patient must have a dysfunction of its vascular access, defined by :
- A stenosis >50% of the venous line must be diagnosed on the initial fistulogram
- A successful plain balloon angioplasty of the stenosis, defined by residual stenosis <30% on control angiogram, without dissection or indication for use of stent or additional surgical procedure, must be completed before inclusion.
Key exclusion criteria (6 listed)
- Pregnant or nursing woman, or plans to become pregnant during the study.
- Patient has hyperkalemia >6,5 mmol/L with EKG modifications or acute cardiac insufficiency at the time of inclusion
- Vascular access has in-stent restenosis
- Initial fistulogram shows no stenosis
- Initial fistulogram shows indication for open surgical intervention
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 Balloon dilatation catheter Advance® (Cook® Medical)2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure | Device | PBA (Plain Balloon Angioplasty) |
| Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure | Device | PTX |
Primary outcome
Primary patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon
Time frame: at 12 months
5 secondary outcomes
Primary patency of the vascular access
Time frame: at 6 months after treatment
Assisted-primary patency of the vascular access
Time frame: at 6 and 12 months after treatment
Secondary patency of the vascular access
Time frame: at 6 and 12 months after treatment
Number of reinterventions (endovascular or surgery)
Time frame: after treatment during the follow-up (at 12 months)
Days of hospitalization for reinterventions (endovascular or surgery)
Time frame: after treatment during the follow-up (at 12 months)
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 2 Dec 2025.
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.
REDA HASSEN-KHODJA principal investigator
Centre Hospitalier Universitaire de Nice
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTA Balloon dilatation catheter Advance® (Cook® Medical) and Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX® in people with Dysfunction of Hemodialysis Vascular Access (Fistula and Graft), run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
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 11 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
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 patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon (time frame: at 12 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 2 Dec 2025.