Stenosis of Arteriovenous Dialysis FistulaFAVABEDNCT02913274
Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty
A study testing Paclitaxel (Taxol) eluting angioplasty balloon, high-pressure angioplasty balloon and low-pressure balloon in people with Stenosis of Arteriovenous Dialysis Fistula, run by Rennes University Hospital at 10 sites in France.
Trial summary
Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the leading cause of hospitalisationand morbidity in chronic haemodialysis patients incurring significant related costs estimated at over one billion dollars in the USA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosis of Arteriovenous Dialysis Fistula
- What is being tested?
- Paclitaxel (Taxol) eluting angioplasty balloon, high-pressure angioplasty balloon and low-pressure balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 10 sitesFrance
- Study dates
- 20 Mar 2017to 21 Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18,
- Stage 5 renal failure patients on permanent haemodialysis treatment (every 2 or 3 days),
- Native and efficient arteriovenous fistula > 3 months,
- 3mm ≤ reference vein diameter ≤ 8 mm and stenosis length ≤ 10 cm (range of DEB diameters and lengths),
- Absence of fistula thrombosis,
- Possibility of crossing the stenosis with a guide wire,
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- Significant stenosis > 50% (in relation to the reference diameter) on the fistulogram,
- Clinical diagnosis of imminent fistula dysfunction
- pressure rise during dialysis
- and/or puncture difficulties
- and/or recirculation or poor extrarenal clearance
- and/or decrease in vascular access flow
- and/or increase in compression time after dialysis
- Social security affiliation,
- Receipt of free, informed, written consent.
Who cannot join
- Multiple stenoses,
- Goretex® graft prostheses
- Systemic or local infection,
- Known allergy to contrast agent or Paclitaxel.
- Comorbidity not permitting long-term follow-up,
- Life expectancy < 1 year,
Show all 9Show fewer
- Anticancer treatment (patients treated with chemotherapy for neoplasia),
- Pregnant or breastfeeding woman,
- Patients over 18 years of age who are under legal protection (conservatorship, trusteeship, guardianship), or deprived of freedom.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Bordeaux
Bordeaux
Centre Hospitalier Universitaire de Caen
Caen
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand
Centre Hospitalier d'Haguenau
Haguenau
APHM Hôpital la Timone
Marseille
Centre Hospitalier Universitaire de Montpellier
Montpellier
Hôpital Européen Georges Pompidou
Paris
Centre Hospitalier Universitaire de RENNES
Rennes
Centre Hospitalier Universitaire de Toulouse
Toulouse
Clinique St Gatien de Tours
Tours
About this study
Official title: Fistules Artério-Veineuses: Angioplastie Par Ballon à Elution de Drogue (FAVABED) - Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty
Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the leading cause of hospitalisationand morbidity in chronic haemodialysis patients incurring significant related costs estimated at over one billion dollars in the USA.
Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as this is the least invasive procedure, the alternative being revision surgery. Angioplasty uses an inflatable balloon of various diameters. Different types of angioplasty balloons may be needed to break fibrous venous stenosis, in particular high-pressure balloons or cutting balloons. These angioplasty procedures which are often painful during dilation have a high technical success rate but a poor 1-year patency rate.
Read more
These invasive repeated procedures impair the quality of life of these patients with end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for whom vascular access patency is vital.
Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis access is the key factor in development of a new stenosis and hence a vicious circle of stenosis-angioplasty.
For the past few years, angioplasty balloons delivering anticancer drugs have been developed. These drugs, generally used in high doses for cancer chemotherapy, are released in small doses on the medical angioplasty devices. During inflation, the local release of the anticancer molecule through the different layers of the vessel wall confers local antiproliferative action without the systemic toxic effects associated with high-dose chemotherapy.
These medical devices have demonstrated their efficacy in terms of increase in primary and secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal or sub-popliteal artery angioplasty.
These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has proven their medical effectiveness, and in particular their contribution in terms of patency rate improvement. However, studies on animal models show significant results regarding efficacy against neointimal hyperplasia and the first single-centre clinical trials on a small sample size appear promising.
The key assessment criterion is primary patency of the dilated stenosis at one year defined by patients efficaciously dialysed at one year without re-intervention on the dilated lesion after initial angioplasty. The delay of occurrence of dilation will be considered. Patients that will be non-evaluable for the primary endpointwill be censored at the date of the latest news.
Read the detailed description
Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the leading cause of hospitalisation (20%) and morbidity in chronic haemodialysis patients incurring significant related costs estimated at over one billion dollars in the USA.
Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as this is the least invasive procedure, the alternative being revision surgery. Angioplasty uses an inflatable balloon of various diameters. Different types of angioplasty balloons may be needed to break fibrous venous stenosis, in particular high-pressure balloons (20 atm) or cutting balloons. These angioplasty procedures which are often painful during dilation have a high technical success rate (90-97%) but a poor 1-year patency rate, varying between 26 and 64% depending on the team and a mean rate estimated at 40% for the studies including the larger number of patients, some of whom requiring several procedures.
These invasive repeated procedures impair the quality of life of these patients with end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for whom vascular access patency is vital.
Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis access is the key factor in development of a new stenosis and hence a vicious circle of stenosis-angioplasty.
For the past few years, angioplasty balloons delivering anticancer drugs (Paclitaxel, Sirolimus, Everolimus) have been developed. These drugs, generally used in high doses for cancer chemotherapy, are released in small doses on the medical angioplasty devices. During inflation, the local release of the anticancer (antimitotic) molecule through the different layers of the vessel wall (Paclitaxel is lipophilic and hydrophobic) confers local antiproliferative action without the systemic toxic effects associated with high-dose chemotherapy.
These medical devices have demonstrated their efficacy in terms of increase in primary and secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal or sub-popliteal artery angioplasty (treatment of angina or lower limb arteriopathy).
These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has proven their medical effectiveness, and in particular their contribution in terms of patency rate improvement. However, studies on animal models show significant results regarding efficacy against neointimal hyperplasia and the first single-centre clinical trials on a small sample size appear promising.
The key assessment criterion is primary patency of the dilated stenosis at one year defined by patients efficaciously dialysed at one year without re-intervention on the dilated lesion after initial angioplasty. The delay of occurrence of dilation will be considered (censored criteria). Patients that will be non-evaluable for the primary endpoint (death, lost to follow-up…) will be censored at the date of the latest news.
- Being tested
- Paclitaxel (Taxol) eluting angioplasty balloon, high-pressure angioplasty balloon, low-pressure balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel (Taxol) eluting angioplasty balloonDevice
Also called BARD, Lutonix® 035 and Lutonix®5F GeoAlign™
Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Then dilatation by a DEB of the same size for 2 minutes.
high-pressure angioplasty balloonDevice
Also called BARD, Conquest®
Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Then dilatation either by a shame balloon or by a DEB balloon of the same size for 2 minutes.
low-pressure balloonDevice
Also called BARD, Ultraverse®
Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Thenn dilatation by a shame balloon i.e conventional low pression balloon of the same size for 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| "DEB" arm | Experimental | dilation by a high-pressure conventional angioplasty balloon (sized to fit the reference native vein diameter) until disappearance of the stenotic obstructive area and achievement of technical success (possibility of changing balloon size or dilation pressure) then dilation by a DEB. Receives: Device: Paclitaxel (Taxol) eluting angioplasty balloon; Device: high-pressure angioplasty balloon |
| "conventional angioplasty" arm | Active comparator | dilation will be performed by a conventional high-pressure balloon until technical success is achieved (possibility of changing balloon size or dilation pressure), then by a sham balloon i.e a conventional low-pressure balloon (placebo) Receives: Device: high-pressure angioplasty balloon; Device: low-pressure balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients whose haemodialysis is efficient at 1 year without needing further treatment of the stenotic site after initial angioplasty
assess the primary patency at 1 year after the dilatation of native AVF stenosis with "active" drug-eluting balloons (DEB) compared to conventional "plain" balloons, i.e to compare between the two groups the number of patients whose haemodialysis is efficient at 1 year without needing further treatment of the stenotic site after initial angioplasty.
Measured: 1 year
Secondary outcomes (6)
primary patency at 6 months
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for primary patency at 6 months of the dilated stenosis
Measured: 6 months
overall primary patency of the Arteriovenous Fistula at 1 year
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for overall primary patency of the Arteriovenous Fistula at 1 year (patency including AVF dysfunction in relation to the initial dilated stenosis as well as stenoses distant from the initially treated site)
Measured: 1 year
assisted primary patency of the dilated stenosis at 1 year
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for assisted primary patency of the dilated stenosis at 1 year: Arteriovenous Fistula patency and continuation of efficient haemodialysis sessions with new angioplasties on the initially dilated stenotic site (excluding de-obstruction for complete thrombosis)
Measured: 1 year
secondary patency of the AVF at 1 year
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for secondary patency of the Arteriovenous Fistula at 1 year: Arteriovenous Fistula patency and continuation of efficient haemodialysis sessions also including complete thrombosis de-obstruction procedures
Measured: 1 year
The minimal diameter of the treated stenosis and the AVF flows
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for the minimal diameter of the treated stenosis (Late Luminal Loss) and the Arteriovenous Fistula flows (both criterion being evaluated by Doppler ultrasound and Transonic® after angioplasty, and at 6 months and 1 year follow-up).
Measured: 1 year
Overall and cardiovascular survival
during analysis in sub-groups, the advantage of these Drug-Eluting Balloons for Overall and cardiovascular survival at 2 and 5 years for all patients and for subgroup of patients with symptomatic peripheral artery disease
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start20 Mar 2017
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
Why it stopped: The study was temporarily suspended after a meta-analysis suggesting higher mortality risks among patients treated with Paclitaxel-coated balloons. When the study was open again, no new patient accepted to be included. The study stopped on 18AUG2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis of Arteriovenous Dialysis FistulaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François Heautot, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913274
- Sponsor's protocol ID
- 2016-A00420-51
- Acronym
- FAVABED
- Status last verified
- Dec 2023
- First submitted
- 20 Sep 2016
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fistules Artério-Veineuses: Angioplastie Par Ballon à Elution de Drogue (FAVABED) - Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty
- ClinicalTrials.gov ID
- NCT02913274
- Acronym / sponsor ID
- FAVABED / 2016-A00420-51
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was temporarily suspended after a meta-analysis suggesting higher mortality risks among patients treated with Paclitaxel-coated balloons. When the study was open again, no new patient accepted to be included. The study stopped on 18AUG2023.
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 23 Sep 2016 (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.
Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the leading cause of hospitalisationand morbidity in chronic haemodialysis patients incurring significant related costs estimated at over one billion dollars in the USA.
Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as this is the least invasive procedure, the alternative being revision surgery. Angioplasty uses an inflatable balloon of various diameters. Different types of angioplasty balloons may be needed to break fibrous venous stenosis, in particular high-pressure balloons or cutting balloons. These angioplasty procedures which are often painful during dilation have a high technical success rate but a poor 1-year patency rate.
These invasive repeated procedures impair the quality of life of these patients with end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for whom vascular access patency is vital.
Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis access is the key factor in development of a new stenosis and hence a vicious circle of stenosis-angioplasty.
For the past few years, angioplasty balloons delivering anticancer drugs have been developed. These drugs, generally used in high doses for cancer chemotherapy, are released in small doses on the medical angioplasty devices. During inflation, the local release of the anticancer molecule through the different layers of the vessel wall confers local antiproliferative action without the systemic toxic effects associated with high-dose chemotherapy.
These medical devices have demonstrated their efficacy in terms of increase in primary and secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal or sub-popliteal artery angioplasty.
These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has proven their medical effectiveness, and in particular their contribution in terms of patency rate improvement. However, studies on animal models show significant results regarding efficacy against neointimal hyperplasia and the first single-centre clinical trials on a small sample size appear promising.
The key assessment criterion is primary patency of the dilated stenosis at one year defined by patients efficaciously dialysed at one year without re-intervention on the dilated lesion after initial angioplasty. The delay of occurrence of dilation will be considered. Patients that will be non-evaluable for the primary endpointwill be censored at the date of the latest news.
Detailed description
Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the leading cause of hospitalisation (20%) and morbidity in chronic haemodialysis patients incurring significant related costs estimated at over one billion dollars in the USA.
Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as this is the least invasive procedure, the alternative being revision surgery. Angioplasty uses an inflatable balloon of various diameters. Different types of angioplasty balloons may be needed to break fibrous venous stenosis, in particular high-pressure balloons (20 atm) or cutting balloons. These angioplasty procedures which are often painful during dilation have a high technical success rate (90-97%) but a poor 1-year patency rate, varying between 26 and 64% depending on the team and a mean rate estimated at 40% for the studies including the larger number of patients, some of whom requiring several procedures.
These invasive repeated procedures impair the quality of life of these patients with end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for whom vascular access patency is vital.
Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis access is the key factor in development of a new stenosis and hence a vicious circle of stenosis-angioplasty.
For the past few years, angioplasty balloons delivering anticancer drugs (Paclitaxel, Sirolimus, Everolimus) have been developed. These drugs, generally used in high doses for cancer chemotherapy, are released in small doses on the medical angioplasty devices. During inflation, the local release of the anticancer (antimitotic) molecule through the different layers of the vessel wall (Paclitaxel is lipophilic and hydrophobic) confers local antiproliferative action without the systemic toxic effects associated with high-dose chemotherapy.
These medical devices have demonstrated their efficacy in terms of increase in primary and secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal or sub-popliteal artery angioplasty (treatment of angina or lower limb arteriopathy).
These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has proven their medical effectiveness, and in particular their contribution in terms of patency rate improvement. However, studies on animal models show significant results regarding efficacy against neointimal hyperplasia and the first single-centre clinical trials on a small sample size appear promising.
The key assessment criterion is primary patency of the dilated stenosis at one year defined by patients efficaciously dialysed at one year without re-intervention on the dilated lesion after initial angioplasty. The delay of occurrence of dilation will be considered (censored criteria). Patients that will be non-evaluable for the primary endpoint (death, lost to follow-up…) will be censored at the date of the latest news.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "DEB" arm | Experimental | Device: Paclitaxel (Taxol) eluting angioplasty balloon, Device: high-pressure angioplasty balloondilation by a high-pressure conventional angioplasty balloon (sized to fit the reference native vein diameter) until disappearance of the stenotic obstructive area and achievement of technical success (possibility of changing balloon size or dilation pressure) then dilation by a DEB. |
| "conventional angioplasty" arm | Active comparator | Device: high-pressure angioplasty balloon, Device: low-pressure balloondilation will be performed by a conventional high-pressure balloon until technical success is achieved (possibility of changing balloon size or dilation pressure), then by a sham balloon i.e a conventional low-pressure balloon (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18,
- Stage 5 renal failure patients on permanent haemodialysis treatment (every 2 or 3 days),
- Native and efficient arteriovenous fistula > 3 months,
- 3mm ≤ reference vein diameter ≤ 8 mm and stenosis length ≤ 10 cm (range of DEB diameters and lengths),
- Absence of fistula thrombosis,
Key exclusion criteria (9 listed)
- Multiple stenoses,
- Goretex® graft prostheses
- Systemic or local infection,
- Known allergy to contrast agent or Paclitaxel.
- Comorbidity not permitting long-term follow-up,
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 |
|---|---|---|
| Paclitaxel (Taxol) eluting angioplasty balloonAlso: BARD, Lutonix® 035 and Lutonix®5F GeoAlign™Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Then dilatation by a DEB of the same size for 2 minutes. | Device | "DEB" arm |
| high-pressure angioplasty balloonAlso: BARD, Conquest®Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Then dilatation either by a shame balloon or by a DEB balloon of the same size for 2 minutes. | Device | "DEB" arm, "conventional angioplasty" arm |
| low-pressure balloonAlso: BARD, Ultraverse®Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Thenn dilatation by a shame balloon i.e conventional low pression balloon of the same size for 2 minutes. | Device | "conventional angioplasty" arm |
Primary outcome
Number of patients whose haemodialysis is efficient at 1 year without needing further treatment of the stenotic site after initial angioplasty
Time frame: 1 year
assess the primary patency at 1 year after the dilatation of native AVF stenosis with "active" drug-eluting balloons (DEB) compared to conventional "plain" balloons, i.e to compare between the two groups the number of patients whose haemodialysis is efficient at 1 year without needing further treatment of the stenotic site after initial angioplasty.
6 secondary outcomes
primary patency at 6 months
Time frame: 6 months
overall primary patency of the Arteriovenous Fistula at 1 year
Time frame: 1 year
assisted primary patency of the dilated stenosis at 1 year
Time frame: 1 year
secondary patency of the AVF at 1 year
Time frame: 1 year
The minimal diameter of the treated stenosis and the AVF flows
Time frame: 1 year
Overall and cardiovascular survival
Time frame: 5 years
Results and safety
The study was stopped early (reason given: The study was temporarily suspended after a meta-analysis suggesting higher mortality risks among patients treated with Paclitaxel-coated balloons. When the study was open again, no new patient accepted to be included. The study stopped on 18AUG2023.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
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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.
Jean-François Heautot, MD principal investigator
Rennes University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel (Taxol) eluting angioplasty balloon, high-pressure angioplasty balloon and low-pressure balloon in people with Stenosis of Arteriovenous Dialysis Fistula, run by Rennes University Hospital at 10 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 15 inclusion and 9 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 26 Dec 2023. 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 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?
The study was stopped early (reason given: The study was temporarily suspended after a meta-analysis suggesting higher mortality risks among patients treated with Paclitaxel-coated balloons. When the study was open again, no new patient accepted to be included. The study stopped on 18AUG2023.). 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?
Number of patients whose haemodialysis is efficient at 1 year without needing further treatment of the stenotic site after initial angioplasty (time frame: 1 year). 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 26 Dec 2023.