Clinical trial NCT06868901: Six-month Response Rate According to Two Surgical Techniques (Rotational Atherectomy Versus Angioplasty) to Treat Stenosis of Vascular Accesses in Hemodialysis.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodialysis Complication
Dialysis Access Malfunction
Stenosis
Keywords: Arteriovascular fistula
Angioplasty
Balloon
Atherectomy
Fistula
Re-stenosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Re-stenosis rate at 6 months in the control group
timeFrame: At 6 months postoperative
measure: Re-stenosis rate at 6 months in the experimental group
timeFrame: At 6 months postoperative
Secondary outcomes:
measure: Time to re-stenosis in the control group
timeFrame: Up to 6 months postoperative
measure: Time to re-stenosis in the experimental group
timeFrame: Up to 6 months postoperative
measure: Rate of complications in the control group
timeFrame: Up to 6 months' follow-up.
measure: Rate of complications in the experimental group
timeFrame: Up to 6 months' follow-up.
measure: Intermediate re-stenosis at 1 month in the control group
timeFrame: At 1 month postoperative
measure: Intermediate re-stenosis at 1 month in the experimental group
timeFrame: At 1 month postoperative
measure: Intermediate re-stenosis at 3 months in the control group
timeFrame: At 3 months postoperative
measure: Intermediate re-stenosis at 3 months in the experimental group
timeFrame: At 3 months postoperative
measure: Systolic velocity in the control group
timeFrame: At 3 months postoperative
measure: Systolic velocity in the experimental group
timeFrame: At 3 months postoperative
measure: Systolic velocity in the control group
timeFrame: At 6 months postoperative
measure: Systolic velocity in the experimental group
timeFrame: At 6 months postoperative
measure: Venous lumen at 1 month in the control group
timeFrame: At 1 month postoperative
measure: Venous lumen at 1 month in the experimental group
timeFrame: At 1 month postoperative
measure: Venous lumen at 3 months in the control group
timeFrame: At 3 months postoperative
measure: Venous lumen at 3 months in the experimental group
timeFrame: At 3 months postoperative
measure: Venous lumen at 6 months in the control group
timeFrame: At 6 months postoperative
measure: Venous lumen at 6 months in the experimental group
timeFrame: At 6 months postoperative
measure: Re-intervention rate for thrombosis in the control group
timeFrame: Up to 6 months postoperative
measure: Re-intervention rate for thrombosis in the experimental group
timeFrame: Up to 6 months postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Vascular and Thoracic Surgery department, Nîmes University Hospital, France
name: Elsa FAURE, Dr.
role: PRINCIPAL_INVESTIGATOR
References: