Hemodialysis ComplicationARSAVNCT06868901
Six-month Response Rate According to Two Surgical Techniques (Rotational Atherectomy Versus Angioplasty) to Treat Stenosis of Vascular Accesses in Hemodialysis.
A study testing Standard angioplasty + drug-eluting balloon technique and Atherectomy + drug-eluting balloon in people with Hemodialysis Complication and Dialysis Access Malfunction, run by Centre Hospitalier Universitaire de Nīmes.
Trial summary
A well-functioning hemodialysis vascular access is a decisive factor in the survival of hemodialysis patients, who have a high mortality rate. 85% of these hemodialysis patients, are treated via an arteriovenous fistula (AVF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Dialysis Access Malfunction, Stenosis
- What is being tested?
- Standard angioplasty + drug-eluting balloon technique and Atherectomy + drug-eluting balloon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Dec 2027
- 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
- Hemodialysis patient on arteriovenous fistula (AVF) with re-stenosis defined on echodoppler by a combination of >50% venous lumen reduction with a systolic peak ratio >2 associated with either : i) an internal residual diameter of < 2 mm, or ii) a flow reduction > 25% or a flow rate < 500 ml/min.
- Patient with at least one history of angioplasty on his/her AVF at the same site.
- Patient available for 6-month follow-up.
- Patient with free and informed consent and signed consent form.
- Patient affiliated with or benefiting from a health insurance plan.
Who cannot join
- Patient with an intraoperative technical impossibility.
- Patient with a septic complication.
- Patient participating in another interventional trial.
- Patient in an exclusion period determined by another study.
- Patient under court protection, guardianship or curatorship.
- Patient unable to give consent.
- Patient for whom it is impossible to give informed information.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the 6-month Response Rate According to Two Surgical Techniques (Rotational Atherectomy vs. Angioplasty) to Treat Stenosis of Vascular Accesses in Hemodialysis. A Single-center, Randomized, Single-blind, Superiority-controlled Pilot Study.
A well-functioning hemodialysis vascular access is a decisive factor in the survival of hemodialysis patients, who have a high mortality rate. 85% of these hemodialysis patients, are treated via an arteriovenous fistula (AVF). However, the primary patency of AVFs at 1 year is 60%, mainly due to neointimal hyperplasia developing in the drainage vein, which leads to stenosis and, if left untreated, thrombosis of the AVF. Indeed, forty percent of hemodialysis patients require re-intervention on their vascular access within the year, due to stenosis on their AVF.
Transluminal angioplasty (TLA) is currently used as first-line treatment for these stenoses but TLA itself causes vascular damage, with early recurrence of the stenosis in 50% of cases at 6 months, and necessitating repeated interventions.
Read more
In recent years several endovascular techniques have been developed to limit the risk of re-stenosis, none of which have produced significantly better results than simple TLA. Eliminating intimal hyperplasia using a minimally invasive endovascular technique, rather than crushing it with simple angioplasty, would improve restenosis-free survival in these patients.
Today, endovascular rotational atherectomy techniques are available to improve the patency of angioplasty in the treatment of complex arterial lesions of the coronary arteries and lower limbs. The atherotome is a guide-mounted catheter with a small burr at its distal end, which resects the atheromatous plaque whereas angioplasty simply crushes it. Atherectomy is followed by drug-eluting balloon (DEB) angioplasty with paclitaxel release to limit restenosis through its anti-inflammatory and anti-proliferative activity. A few cases of rotational atherectomy for the treatment of calcified stenoses in saphenous vein coronary bypasses have been reported in the literature, with encouraging results. If AVF re-stenosis should occur, the intimal hyperplasia can be removed endovascularly, thereby limiting the risk of short-term iterative stenosis.
The aim of this study was to compare the 6-month re-stenosis rate with this technique (atherectomy + drug-eluting balloon) versus standard angioplasty + drug-eluting balloon for the treatment of restenosis of hemodialysis vascular accesses.
Read the detailed description
A well-functioning hemodialysis vascular access is a decisive factor in the survival of hemodialysis patients, who have a high mortality rate. 85% of these hemodialysis patients, are treated via an arteriovenous fistula (AVF), which is currently the access offering the best results in terms of patency and infectious risk. However, the primary patency of AVFs at 1 year is 60%, mainly due to the development of neointimal hyperplasia in the drainage vein, which leads to stenosis and, if left untreated, thrombosis of the AVF. Forty percent of hemodialysis patients on AVF will therefore have at least one intervention on their vascular access within the year, due to stenosis on their AVF.
Transluminal angioplasty (TLA) is currently used as first-line treatment for these stenoses. However, TLA itself causes vascular damage, with migration and myofibroblast proliferation responsible for abnormal vascular remodeling, leading to early recurrence of the stenosis in 50% of cases at 6 months, limiting the long-term functionality of these angioplasties and necessitating repeated interventions on these patients. For all these reasons, developing techniques to limit the risk of re-stenosis of hemodialysis AVFs is a public health issue.
In recent years several endovascular techniques have been developed to limit the risk of re-stenosis: paclitaxel-coated "active" balloon angioplasty, bare or covered stenting, none of which have produced significantly better results than simple TLA. Eliminating intimal hyperplasia using a minimally invasive endovascular technique, rather than crushing it with simple angioplasty, would improve restenosis-free survival in these patients, without increasing the burden of management.
Today, endovascular rotational atherectomy techniques are available to improve the patency of angioplasty in the treatment of complex arterial lesions of the coronary arteries and lower limbs. The atherotome is a guide-mounted catheter with a small burr at its distal end, which resects the atheromatous plaque where angioplasty simply crushes it. Atherectomy is followed by drug-eluting balloon angioplasty with paclitaxel release to limit restenosis through its anti-inflammatory and anti-proliferative activity. A few cases of rotational atherectomy for the treatment of calcified stenoses in saphenous vein coronary bypasses have been reported in the literature, with encouraging results and the absence of complications, notably perforation. If AVF re-stenosis should occur, the intimal hyperplasia can be removed endovascularly, thereby limiting the risk of short-term iterative stenosis.
The aim of this study was to compare the 6-month re-stenosis rate with this technique (atherectomy + drug-eluting balloon) versus standard angioplasty + drug-eluting balloon for the treatment of restenosis of hemodialysis vascular accesses.
- Being tested
- Standard angioplasty + drug-eluting balloon technique, Atherectomy + drug-eluting balloon
- Keywords
- Arteriovascular fistula, Angioplasty, Balloon, Atherectomy, Fistula, Re-stenosis
- Medical subject headings
- Constriction, Pathologic, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard angioplasty + drug-eluting balloon techniqueProcedure or surgery
Treatment of restenosis of hemodialysis vascular access via the standard angioplasty + drug-eluting balloon technique
Atherectomy + drug-eluting balloonProcedure or surgery
Treatment of restenosis of hemodialysis vascular access via the atherectomy + drug-eluting balloon technique
| Study group | Role | What they receive |
|---|---|---|
| Control group (ANG) | Active comparator | Treatment of re-stenosis of hemodialysis vascular access using the standard angioplasty + drug-eluting balloon technique. Receives: Procedure: Standard angioplasty + drug-eluting balloon technique |
| Experimental group (ATH) | Active comparator | Treatment of re-stenosis of hemodialysis vascular access using the atherectomy + drug-eluting balloon technique. Receives: Procedure: Atherectomy + drug-eluting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-stenosis rate at 6 months in the control group
YES/NO Significant restenosis is defined on echodoppler by a combination of > 50% venous lumen reduction with a systolic peak ratio > 2 associated with: i) either an internal residual diameter < 2 mm, ii) or a flow reduction > 25% or flow < 500 ml/min.
Measured: At 6 months postoperative
Re-stenosis rate at 6 months in the experimental group
YES/NO Significant restenosis is defined on echodoppler by a combination of > 50% venous lumen reduction with a systolic peak ratio > 2 associated with: i) either an internal residual diameter < 2 mm, ii) or a flow reduction > 25% or flow < 500 ml/min.
Measured: At 6 months postoperative
Secondary outcomes (20)
Time to re-stenosis in the control group
Time (days) from surgery to onset of restenosis as defined above.
Measured: Up to 6 months postoperative
Time to re-stenosis in the experimental group
Time (days) from surgery to onset of restenosis as defined above.
Measured: Up to 6 months postoperative
Rate of complications in the control group
Collection of complications related to surgical technique: perforation (assessed by the operator intraoperatively: extravasation of contrast medium at fistulographic control), false aneurysm (assessed at follow-up echodoppler).
Measured: Up to 6 months' follow-up.
Rate of complications in the experimental group
Collection of complications related to surgical technique: perforation (assessed by the operator intraoperatively: extravasation of contrast medium at fistulographic control), false aneurysm (assessed at follow-up echodoppler).
Measured: Up to 6 months' follow-up.
Intermediate re-stenosis at 1 month in the control group
Intermediate patency assessed by significant restenosis as defined above
Measured: At 1 month postoperative
Intermediate re-stenosis at 1 month in the experimental group
Intermediate patency assessed by significant restenosis as defined above
Measured: At 1 month postoperative
Intermediate re-stenosis at 3 months in the control group
Intermediate patency assessed by significant restenosis as defined above
Measured: At 3 months postoperative
Intermediate re-stenosis at 3 months in the experimental group
Intermediate patency assessed by significant restenosis as defined above
Measured: At 3 months postoperative
Systolic velocity in the control group
Systolic velocity (ml/s) assessed by echodoppler
Measured: At 3 months postoperative
Systolic velocity in the experimental group
Systolic velocity (ml/s) assessed by echodoppler
Measured: At 3 months postoperative
Systolic velocity in the control group
Systolic velocity (ml/s) assessed by echodoppler
Measured: At 6 months postoperative
Systolic velocity in the experimental group
Systolic velocity (ml/s) assessed by echodoppler
Measured: At 6 months postoperative
Venous lumen at 1 month in the control group
Measurement of venous lumen as a percentage on echodoppler
Measured: At 1 month postoperative
Venous lumen at 1 month in the experimental group
Measurement of venous lumen as a percentage on echodoppler
Measured: At 1 month postoperative
Venous lumen at 3 months in the control group
Measurement of venous lumen as a percentage on echodoppler
Measured: At 3 months postoperative
Venous lumen at 3 months in the experimental group
Measurement of venous lumen as a percentage on echodoppler
Measured: At 3 months postoperative
Venous lumen at 6 months in the control group
Measurement of venous lumen as a percentage on echodoppler
Measured: At 6 months postoperative
Venous lumen at 6 months in the experimental group
Measurement of venous lumen as a percentage on echodoppler
Measured: At 6 months postoperative
Re-intervention rate for thrombosis in the control group
Occurrence of re-intervention for thrombosis: yes/no.
Measured: Up to 6 months postoperative
Re-intervention rate for thrombosis in the experimental group
Occurrence of re-intervention for thrombosis: yes/no.
Measured: Up to 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single-center, randomized (ratio 1:1), single-blind (patient), superiority controlled study comparing two surgical techniques for the treatment of restenosis of hemodialysis vascular access: atherectomy + drug-eluting balloon (experimental group "ATH") versus standard angioplasty + drug-eluting balloon (control group "ANG"). The impact of atherectomy with drug-eluting balloon for the treatment of arteriovenous fistula (AVF) restenosis at 6 months after surgery will be assessed via a comparator group (angioplasty with drug-eluting balloon) and on the basis of a specific judgement criterion, i.e. the occurrence of re-stenosis at this time.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elsa FAURE, Dr., Principal investigator, Vascular and Thoracic Surgery department, Nîmes University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868901
- Sponsor's protocol ID
- NIMAO/2024-1/EF01
- Acronym
- ARSAV
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is managed by the BESPIM (Biostatistics Epidemiology Public Health \& Innovation in Methodology) of the Nîmes University Hospital. The conditions for transferring all or part of the research database are decided by the research sponsor, and will be set out in a written contract.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the 6-month Response Rate According to Two Surgical Techniques (Rotational Atherectomy vs. Angioplasty) to Treat Stenosis of Vascular Accesses in Hemodialysis. A Single-center, Randomized, Single-blind, Superiority-controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT06868901
- Acronym / sponsor ID
- ARSAV / NIMAO/2024-1/EF01
- Keywords
- Arteriovascular fistula, Angioplasty, Balloon, Atherectomy, Fistula, Re-stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Mar 2025 (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.
A well-functioning hemodialysis vascular access is a decisive factor in the survival of hemodialysis patients, who have a high mortality rate. 85% of these hemodialysis patients, are treated via an arteriovenous fistula (AVF). However, the primary patency of AVFs at 1 year is 60%, mainly due to neointimal hyperplasia developing in the drainage vein, which leads to stenosis and, if left untreated, thrombosis of the AVF. Indeed, forty percent of hemodialysis patients require re-intervention on their vascular access within the year, due to stenosis on their AVF.
Transluminal angioplasty (TLA) is currently used as first-line treatment for these stenoses but TLA itself causes vascular damage, with early recurrence of the stenosis in 50% of cases at 6 months, and necessitating repeated interventions.
In recent years several endovascular techniques have been developed to limit the risk of re-stenosis, none of which have produced significantly better results than simple TLA. Eliminating intimal hyperplasia using a minimally invasive endovascular technique, rather than crushing it with simple angioplasty, would improve restenosis-free survival in these patients.
Today, endovascular rotational atherectomy techniques are available to improve the patency of angioplasty in the treatment of complex arterial lesions of the coronary arteries and lower limbs. The atherotome is a guide-mounted catheter with a small burr at its distal end, which resects the atheromatous plaque whereas angioplasty simply crushes it. Atherectomy is followed by drug-eluting balloon (DEB) angioplasty with paclitaxel release to limit restenosis through its anti-inflammatory and anti-proliferative activity. A few cases of rotational atherectomy for the treatment of calcified stenoses in saphenous vein coronary bypasses have been reported in the literature, with encouraging results. If AVF re-stenosis should occur, the intimal hyperplasia can be removed endovascularly, thereby limiting the risk of short-term iterative stenosis.
The aim of this study was to compare the 6-month re-stenosis rate with this technique (atherectomy + drug-eluting balloon) versus standard angioplasty + drug-eluting balloon for the treatment of restenosis of hemodialysis vascular accesses.
Detailed description
A well-functioning hemodialysis vascular access is a decisive factor in the survival of hemodialysis patients, who have a high mortality rate. 85% of these hemodialysis patients, are treated via an arteriovenous fistula (AVF), which is currently the access offering the best results in terms of patency and infectious risk. However, the primary patency of AVFs at 1 year is 60%, mainly due to the development of neointimal hyperplasia in the drainage vein, which leads to stenosis and, if left untreated, thrombosis of the AVF. Forty percent of hemodialysis patients on AVF will therefore have at least one intervention on their vascular access within the year, due to stenosis on their AVF.
Transluminal angioplasty (TLA) is currently used as first-line treatment for these stenoses. However, TLA itself causes vascular damage, with migration and myofibroblast proliferation responsible for abnormal vascular remodeling, leading to early recurrence of the stenosis in 50% of cases at 6 months, limiting the long-term functionality of these angioplasties and necessitating repeated interventions on these patients. For all these reasons, developing techniques to limit the risk of re-stenosis of hemodialysis AVFs is a public health issue.
In recent years several endovascular techniques have been developed to limit the risk of re-stenosis: paclitaxel-coated "active" balloon angioplasty, bare or covered stenting, none of which have produced significantly better results than simple TLA. Eliminating intimal hyperplasia using a minimally invasive endovascular technique, rather than crushing it with simple angioplasty, would improve restenosis-free survival in these patients, without increasing the burden of management.
Today, endovascular rotational atherectomy techniques are available to improve the patency of angioplasty in the treatment of complex arterial lesions of the coronary arteries and lower limbs. The atherotome is a guide-mounted catheter with a small burr at its distal end, which resects the atheromatous plaque where angioplasty simply crushes it. Atherectomy is followed by drug-eluting balloon angioplasty with paclitaxel release to limit restenosis through its anti-inflammatory and anti-proliferative activity. A few cases of rotational atherectomy for the treatment of calcified stenoses in saphenous vein coronary bypasses have been reported in the literature, with encouraging results and the absence of complications, notably perforation. If AVF re-stenosis should occur, the intimal hyperplasia can be removed endovascularly, thereby limiting the risk of short-term iterative stenosis.
The aim of this study was to compare the 6-month re-stenosis rate with this technique (atherectomy + drug-eluting balloon) versus standard angioplasty + drug-eluting balloon for the treatment of restenosis of hemodialysis vascular accesses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, single-center, randomized (ratio 1:1), single-blind (patient), superiority controlled study comparing two surgical techniques for the treatment of restenosis of hemodialysis vascular access: atherectomy + drug-eluting balloon (experimental group "ATH") versus standard angioplasty + drug-eluting balloon (control group "ANG"). The impact of atherectomy with drug-eluting balloon for the treatment of arteriovenous fistula (AVF) restenosis at 6 months after surgery will be assessed via a comparator group (angioplasty with drug-eluting balloon) and on the basis of a specific judgement criterion, i.e. the occurrence of re-stenosis at this time.
| Arm | Type | Receives |
|---|---|---|
| Control group (ANG) | Active comparator | Procedure: Standard angioplasty + drug-eluting balloon techniqueTreatment of re-stenosis of hemodialysis vascular access using the standard angioplasty + drug-eluting balloon technique. |
| Experimental group (ATH) | Active comparator | Procedure: Atherectomy + drug-eluting balloonTreatment of re-stenosis of hemodialysis vascular access using the atherectomy + drug-eluting balloon technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hemodialysis patient on arteriovenous fistula (AVF) with re-stenosis defined on echodoppler by a combination of >50% venous lumen reduction with a systolic peak ratio >2 associated with either : i) an internal residual diameter of < 2 mm, or ii) a flow reduction > 25% or a flow rate < 500 ml/min.
- Patient with at least one history of angioplasty on his/her AVF at the same site.
- Patient available for 6-month follow-up.
- Patient with free and informed consent and signed consent form.
- Patient affiliated with or benefiting from a health insurance plan.
Key exclusion criteria (7 listed)
- Patient with an intraoperative technical impossibility.
- Patient with a septic complication.
- Patient participating in another interventional trial.
- Patient in an exclusion period determined by another study.
- Patient under court protection, guardianship or curatorship.
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 |
|---|---|---|
| Standard angioplasty + drug-eluting balloon techniqueTreatment of restenosis of hemodialysis vascular access via the standard angioplasty + drug-eluting balloon technique | Procedure or surgery | Control group (ANG) |
| Atherectomy + drug-eluting balloonTreatment of restenosis of hemodialysis vascular access via the atherectomy + drug-eluting balloon technique | Procedure or surgery | Experimental group (ATH) |
Primary outcome
Re-stenosis rate at 6 months in the control group
Time frame: At 6 months postoperative
YES/NO Significant restenosis is defined on echodoppler by a combination of > 50% venous lumen reduction with a systolic peak ratio > 2 associated with: i) either an internal residual diameter < 2 mm, ii) or a flow reduction > 25% or flow < 500 ml/min.
Re-stenosis rate at 6 months in the experimental group
Time frame: At 6 months postoperative
YES/NO Significant restenosis is defined on echodoppler by a combination of > 50% venous lumen reduction with a systolic peak ratio > 2 associated with: i) either an internal residual diameter < 2 mm, ii) or a flow reduction > 25% or flow < 500 ml/min.
20 secondary outcomes
Time to re-stenosis in the control group
Time frame: Up to 6 months postoperative
Time to re-stenosis in the experimental group
Time frame: Up to 6 months postoperative
Rate of complications in the control group
Time frame: Up to 6 months' follow-up.
Rate of complications in the experimental group
Time frame: Up to 6 months' follow-up.
Intermediate re-stenosis at 1 month in the control group
Time frame: At 1 month postoperative
Intermediate re-stenosis at 1 month in the experimental group
Time frame: At 1 month postoperative
Intermediate re-stenosis at 3 months in the control group
Time frame: At 3 months postoperative
Intermediate re-stenosis at 3 months in the experimental group
Time frame: At 3 months postoperative
Systolic velocity in the control group
Time frame: At 3 months postoperative
Systolic velocity in the experimental group
Time frame: At 3 months postoperative
Systolic velocity in the control group
Time frame: At 6 months postoperative
Systolic velocity in the experimental group
Time frame: At 6 months postoperative
Venous lumen at 1 month in the control group
Time frame: At 1 month postoperative
Venous lumen at 1 month in the experimental group
Time frame: At 1 month postoperative
Venous lumen at 3 months in the control group
Time frame: At 3 months postoperative
Venous lumen at 3 months in the experimental group
Time frame: At 3 months postoperative
Venous lumen at 6 months in the control group
Time frame: At 6 months postoperative
Venous lumen at 6 months in the experimental group
Time frame: At 6 months postoperative
Re-intervention rate for thrombosis in the control group
Time frame: Up to 6 months postoperative
Re-intervention rate for thrombosis in the experimental group
Time frame: Up to 6 months postoperative
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 11 Mar 2025.
- Individual participant dataSharing planned: No. Data is managed by the BESPIM (Biostatistics Epidemiology Public Health \& Innovation in Methodology) of the Nîmes University Hospital. The conditions for transferring all or part of the research database are decided by the research sponsor, and will be set out in a written contract.
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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.
Elsa FAURE, Dr. principal investigator
Vascular and Thoracic Surgery department, Nîmes University Hospital, France
Questions about this trial
What is this clinical trial studying?
A study testing Standard angioplasty + drug-eluting balloon technique and Atherectomy + drug-eluting balloon in people with Hemodialysis Complication and Dialysis Access Malfunction, run by Centre Hospitalier Universitaire de Nīmes.
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 7 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: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Elsa FAURE, Dr. (+334.66.68.77.06, elsa.faure@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-stenosis rate at 6 months in the control group (time frame: At 6 months postoperative). 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?
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 11 Mar 2025; AzTrials last refreshed its copy on 3 Nov 2026.