Medico-economic Evaluation of the Creation of Arteriovenous Access for Hemodialysis Between Surgi… (NCT06679907) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Medico-economic Evaluation of the Creation of Arteriovenous Access for Hemodialysis Between Surgical Technique and Endovascular Technique in Patients with End-stage Renal Disease
France252 participantsStarted 2025-01-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients:
* Age\> 18 years
* On chronic dialysis, or due to start chronic dialysis within 3 to 6 months
* Patient eligible for the creation of a native surgical AVF at the elbow crease and an endovenous AVF according to the instructions for use of the manufacturers of the two devices used, namely:
* Target venous diameter for fistula creation \> or = 3 mm
* Target arterial diameter for fistula creation \> or = 2 mm
* Artery to vein distance \< or = 1.5mm
* At least one superficial outflow vein with a diameter ≥ 2.5 mm connected via a proximal forearm perforating vein with the target site
* Patency of the radial and ulnar arteries confirmed by Doppler ultrasound
* Presence of a connecting perforator between the deep and superficial venous network, relatively straight anatomy
* Distance between proximal radial artery and perforator junction/radial vein \< 1.5mm
* Patient having been clearly informed about the study and having agreed to participate and attend follow-up visits
* Patient affiliated or beneficiary of a social security scheme.
Exclusion Criteria:
* Known central venous stenosis \> 50% on imaging or presence of an indwelling central venous catheter or pacemaker on the same side as the side of creation of the AVF
* Upper extremity arterial occlusive disease not amenable to endovascular or open repair
* Eligibility for a native distal AVF (radio or ulno-cephalic)
* New York Heart Association (NYHA) class III or IV heart failure
* Hypercoagulable…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cost-utility differential ratio (expressed as cost per Quality-Adjusted Life Year [QALY]) with endovascular AVF vs. open surgery