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NCT06679907Not yet recruiting

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

Cost-effectiveness Study Comparing Endovascular and Surgical Arteriovenous Fistula Creation for Haemodialysis in Patients with End-stage Renal Failure

Source: ClinicalTrials.gov · Last updated 14 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
252 (estimated)
First submitted
5 Nov 2024
Start date
15 Jan 2025
Primary completion date
15 Jan 2030
Lead sponsor
University Hospital, Bordeaux
NCT number
NCT06679907

What you commit to

  • Study type: Interventional
  • Planned participants: 252
  • From 15 Jan 2025 to the primary completion date, 15 Jan 2030
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Upper extremity arterial occlusive disease not amenable to endovascular or open repair
  • New York Heart Association (NYHA) class III or IV heart failure
  • Known allergies to medical devices and medications used in the protocol

Other

  • 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
  • Eligibility for a native distal AVF (radio or ulno-cephalic)
  • Hypercoagulable state
  • Estimated life expectancy \<1 year
  • Pregnantly or breastfeeding woman
  • Inability to collect consent
  • Patient not affiliated to a social security scheme

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Polyclinique Bordeaux Nord Aquitaine - Centre Aquitain des pathologies vasculaire
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BordeauxFranceUnknown status
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceUnknown status
AP-HP Centre Hospitalier Universitaire d'Ambroise Paré
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Boulogne-BillancourtFranceUnknown status
Clinique du parc
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Castelnau-le-LezFranceUnknown status
Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage
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DijonFranceUnknown status
Centre Hospitalier Mutualiste de Grenoble
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GrenobleFranceUnknown status
Centre Hospitalier St Joseph - St Luc
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LyonFranceUnknown status
Hôpital Privé Jean Mermoz
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LyonFranceUnknown status
Centre Hospitalier Universitaire de Nice - Hôpital Pasteur 1
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NiceFranceUnknown status
Groupe Hospitalier Paris St Joseph - Centre Hospitalier Chartres
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ParisFranceUnknown status
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
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Saint-HerblainFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.