Six-month Response Rate According to Two Surgical Techniques (Rotational Atherectomy Versus Angioplasty) to Treat Stenosis of Vascular Accesses in Hemodialysis. (ARSAV)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialysis Complication; Stenosis; Dialysis Access Malfunction
• Intervention / Treatment: Procedure: Standard angioplasty + drug-eluting balloon technique; Procedure: Atherectomy + drug-eluting balloon

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anissa MEGZARI; Phone Number: 0466684236; Email: drc@chu-nimes.fr
• Study Contact Backup: Name: Elsa FAURE, Dr.; Phone Number: +334.66.68.77.06; Email: elsa.faure@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group (ANG); Treatment of re-stenosis of hemodialysis vascular access using the standard angioplasty + drug-eluting balloon technique.	Procedure: Standard angioplasty + drug-eluting balloon technique; Treatment of restenosis of hemodialysis vascular access via the standard angioplasty + drug-eluting balloon technique
Active Comparator: Experimental group (ATH); Treatment of re-stenosis of hemodialysis vascular access using the atherectomy + drug-eluting balloon technique.	Procedure: Atherectomy + drug-eluting balloon; Treatment of restenosis of hemodialysis vascular access via the atherectomy + drug-eluting balloon technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At 6 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to re-stenosis in the control group	Time (days) from surgery to onset of restenosis as defined above.	Up to 6 months postoperative
Time to re-stenosis in the experimental group	Time (days) from surgery to onset of restenosis as defined above.	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).	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).	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	At 1 month postoperative
Intermediate re-stenosis at 1 month in the experimental group	Intermediate patency assessed by significant restenosis as defined above	At 1 month postoperative
Intermediate re-stenosis at 3 months in the control group	Intermediate patency assessed by significant restenosis as defined above	At 3 months postoperative
Intermediate re-stenosis at 3 months in the experimental group	Intermediate patency assessed by significant restenosis as defined above	At 3 months postoperative
Systolic velocity in the control group	Systolic velocity (ml/s) assessed by echodoppler	At 3 months postoperative
Systolic velocity in the experimental group	Systolic velocity (ml/s) assessed by echodoppler	At 3 months postoperative
Systolic velocity in the control group	Systolic velocity (ml/s) assessed by echodoppler	At 6 months postoperative
Systolic velocity in the experimental group	Systolic velocity (ml/s) assessed by echodoppler	At 6 months postoperative
Venous lumen at 1 month in the control group	Measurement of venous lumen as a percentage on echodoppler	At 1 month postoperative
Venous lumen at 1 month in the experimental group	Measurement of venous lumen as a percentage on echodoppler	At 1 month postoperative
Venous lumen at 3 months in the control group	Measurement of venous lumen as a percentage on echodoppler	At 3 months postoperative
Venous lumen at 3 months in the experimental group	Measurement of venous lumen as a percentage on echodoppler	At 3 months postoperative
Venous lumen at 6 months in the control group	Measurement of venous lumen as a percentage on echodoppler	At 6 months postoperative
Venous lumen at 6 months in the experimental group	Measurement of venous lumen as a percentage on echodoppler	At 6 months postoperative
Re-intervention rate for thrombosis in the control group	Occurrence of re-intervention for thrombosis: yes/no.	Up to 6 months postoperative
Re-intervention rate for thrombosis in the experimental group	Occurrence of re-intervention for thrombosis: yes/no.	Up to 6 months postoperative

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Elsa FAURE, Dr., Vascular and Thoracic Surgery department, Nîmes University Hospital, France

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Angioplasty; Fistula; Atherectomy; Balloon; Arteriovascular fistula; Re-stenosis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: NIMAO/2024-1/EF01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No