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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Study summary

This multicenter 1 :1 randomized controlled trial aims at comparing the cost-effectiveness of endovascular arteriovenous fistula (AVF) creation using Ellipsys® and WaveLinQ® devices with traditional surgical AVF creation for hemodialysis. The primary endpoint is the cost-utility ratio (cost per QALY gained), with an anticipated sample size of 252 patients. This study will provide critical insights into the viability and cost-effectiveness of endovascular techniques, potentially shaping future standards of care in hemodialysis access.

Eligibility

Primary outcome measure(s)

• Cost-utility differential ratio (expressed as cost per Quality-Adjusted Life Year [QALY]) with endovascular AVF vs. open surgery — month 18
  This measure evaluates the cost-utility ratio by calculating the cost per QALY gained with the creation of an endovascular AVF using WaveLinQ® or Ellipsys® devices compared to an open surgical approach at 18 months. The assessment includes initial hospitalization costs via micro-costing and outpatient costs derived from the National Health Data System (SNDS) and evaluates utility using the EQ-5D-5L questionnaire.

Trial sites (11)

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