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

NCT06868901 | Not Yet Recruiting

• 1 other identifier: NIMAO/2024-1/EF01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemodialysis Complication; Dialysis Access Malfunction; Stenosis

Keywords

Arteriovascular fistula; Angioplasty; Balloon; Atherectomy; Fistula; Re-stenosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Time to re-stenosis in the control group

  Up to 6 months postoperative

• Time to re-stenosis in the experimental group

  Up to 6 months postoperative

• Rate of complications in the control group

  Up to 6 months' follow-up.

• Rate of complications in the experimental group

  Up to 6 months' follow-up.

• Intermediate re-stenosis at 1 month in the control group

  At 1 month postoperative

Study Arms (2)

Control group (ANG)

ACTIVE COMPARATOR

Treatment of re-stenosis of hemodialysis vascular access using the standard angioplasty + drug-eluting balloon technique.

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.

Procedure: Atherectomy + drug-eluting balloon

Interventions

Standard angioplasty + drug-eluting balloon technique PROCEDURE

Treatment of restenosis of hemodialysis vascular access via the standard angioplasty + drug-eluting balloon technique

Control group (ANG)

Atherectomy + drug-eluting balloon PROCEDURE

Treatment of restenosis of hemodialysis vascular access via the atherectomy + drug-eluting balloon technique

Experimental group (ATH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient with an intraoperative technical impossibility.
• Patient with a septic complication.
• Patient participating in another interventional trial.
• Patient under court protection, guardianship or curatorship.
• Patient unable to give consent.
• Patient for whom it is impossible to give informed information.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

MeSH Terms

Conditions

Constriction, Pathologic; Fistula

Interventions

Atherectomy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Elsa FAURE, Dr.

  Vascular and Thoracic Surgery department, Nîmes University Hospital, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elsa FAURE, Dr.

CONTACT

+334.66.68.77.06; elsa.faure@chu-nimes.fr

Anissa MEGZARI

CONTACT

0466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient is blinded to his or her group. The ultrasonographer performing the echodoppler examinations is blinded to the patient's home group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share