Medico-economic Evaluation of the Creation of Arteriovenous Access for Hemodialysis Between Surgical Technique and Endovascular Technique in Patients with End-stage Renal Disease

NANot yet recruitingINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

January 15, 2030

Study Completion Date

January 15, 2030

Conditions
Endovascular ProcedureHemodialysis
Interventions
DEVICE

WaveLinQ® device

The WaveLinQ® system employs a dual catheter technique to establish communication between deep arteries and veins, typically using a ulnar or radial artery and vein. This procedure necessitates fluoroscopic guidance to position the catheters correctly, a control angiogram, and potential embolization to enhance blood flow.

DEVICE

Ellipsys® device

The Ellipsys® system enables the entire AVF creation process to be conducted under ultrasound guidance without the need for fluoroscopy or contrast media. It uses a single needle to puncture the superficial vein, the perforator and the artery and potential balloon angioplasty to enhance blood flow.

DEVICE

No device

Surgical AVF creation will involve a direct approach to the proximal radial, ulnar, or brachial artery to create a 4-6 mm longitudinal arteriotomy. An oblique incision will be made at the elbow crease. The cephalic, basilic, or perforating vein may be used for the side-to-end anastomosis. If a transposition is required due to adiposity, it will be performed either during the same procedure or at a later time through tunneling or lipectomy.

Trial Locations (11)

21000

Centre Hospitalier Universitaire de Dijon - Hôpital le Bocage, Dijon

33000

Centre Hospitalier Universitaire de Bordeaux, Bordeaux

33200

Polyclinique Bordeaux Nord Aquitaine - Centre Aquitain des pathologies vasculaire, Bordeaux

34170

Clinique du parc, Castelnau-le-Lez

38000

Centre Hospitalier Mutualiste de Grenoble, Grenoble

44800

Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec, Saint-Herblain

69000

Hôpital privé Jean Mermoz, Lyon

69007

Centre Hospitalier St Joseph - St Luc, Lyon

75014

Groupe Hospitalier Paris St Joseph - Centre Hospitalier Chartres, Paris

92100

AP-HP Centre Hospitalier Universitaire d'Ambroise Paré, Boulogne-Billancourt

06000

Centre Hospitalier Universitaire de Nice - Hôpital Pasteur 1, Nice

All Listed Sponsors
lead

University Hospital, Bordeaux

OTHER

NCT06679907 - Medico-economic Evaluation of the Creation of Arteriovenous Access for Hemodialysis Between Surgical Technique and Endovascular Technique in Patients with End-stage Renal Disease | Biotech Hunter | Biotech Hunter