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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is examining two different surgical techniques to treat a common problem in hemodialysis patients called stenosis, which is a narrowing of blood vessels that can affect the effectiveness of their treatment. The two methods being compared are rotational atherectomy, which removes the blockage in a gentler way, versus standard angioplasty, which tends to crush the blockage. The goal is to see which method leads to a lower rate of re-narrowing (or re-stenosis) of the blood vessel after six months.

To be eligible for this trial, participants must be hemodialysis patients using an arteriovenous fistula (AVF) who have experienced re-stenosis, meaning their blood vessels have narrowed significantly again after previous treatment. They should be willing to follow up for six months after the procedure. Participants will have a chance to contribute to important research that may improve treatment options for future hemodialysis patients. It's important to note that some individuals may be excluded from the trial, such as those with certain complications or those unable to provide consent.

Gender

ALL

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.