NCT06868901: ARSAV

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

Not yet recruiting NA Last updated 11 March 2025

What this trial tests

NA trial testing Standard angioplasty + drug-eluting balloon technique in Hemodialysis Complication in 40 participants. Not yet recruiting.

Timeline

1 March 2025

Primary endpoint
1 March 2027

1 December 2027

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nīmes
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	40
Start date	1 March 2025
Primary completion	1 March 2027
Estimated completion	1 December 2027

Drugs / interventions tested

• Standard angioplasty + drug-eluting balloon technique
• Atherectomy + drug-eluting balloon

Conditions studied

• Hemodialysis Complication — all drugs for Hemodialysis Complication →
• Dialysis Access Malfunction — all drugs for Dialysis Access Malfunction →
• Stenosis — all drugs for Stenosis →

Sponsor

Centre Hospitalier Universitaire de Nīmes

Who can join

18 and older, any sex, with Hemodialysis Complication or Dialysis Access Malfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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). 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.