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Endovascular ProcedureENDOFAVNCT06679907

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

A study testing WaveLinQ® device, Ellipsys® device and No device in people with Endovascular Procedure and Hemodialysis, run by University Hospital, Bordeaux at 11 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Endovascular Procedure, Hemodialysis
What is being tested?
WaveLinQ® device, Ellipsys® device and No device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
11 sitesFrance
Study dates
15 Jan 2025to 15 Jan 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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 state
  • Estimated life expectancy <1 year
Show all 10Show fewer
  • Pregnantly or breastfeeding woman
  • Known allergies to medical devices and medications used in the protocol
  • Inability to collect consent
  • Patient not affiliated to a social security scheme

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eric DUCASSE, MD, PhD contact

+33556795525

eric.ducasse@chu-bordeaux.fr

11 sites in 1 country

France11 sites

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33000

    Eric DUCASSE, MD, PhD, +33556795525, eric.ducasse@chu-bordeaux.fr

    Olivier DELORME, +33557820459, olivier.delorme@chu-bordeaux.fr

  • Polyclinique Bordeaux Nord Aquitaine - Centre Aquitain des pathologies vasculaire

    Bordeaux, 33200

    Julien LANCELEVEE, +335 56 45 81 81, julienlancelevee@gmail.com

    Julien LANCELEVEE

  • AP-HP Centre Hospitalier Universitaire d'Ambroise Paré

    Boulogne-Billancourt, 92100

    Raphael COSCAS, MD, PhD, +33149095585, raphael.coscas@aphp.fr

    Raphael COSCAS

  • Clinique du parc

    Castelnau-le-Lez, 34170

    Mathieu PECHER, +33467868141, doc.pecher@gmail.com

    Mathieu PECHER

  • Centre Hospitalier Universitaire de Dijon - Hôpital le Bocage

    Dijon, 21000

    Eric STEINMETZ, +33380281294, eric.steinmetz@chu-dijon.fr

    Eric STEINMETZ

  • Centre Hospitalier Mutualiste de Grenoble

    Grenoble, 38000

    Carmine SESSA Carmine, +334 76 70 72 67, carmine.sessa@avec.fr

    Carmine SESSA

  • Hôpital privé Jean Mermoz

    Lyon, 69000

    Guillaume DANIEL Guillaume, +334 72 69 50 80, gdaniel.vasc@gmail.com

    Guillaume DANIEL

  • Centre Hospitalier St Joseph - St Luc

    Lyon, 69007

    Yann PAQUET, +334 78 61 85 83, ypaquet@saintjosephsaintluc.fr

    Yann PAQUET

  • Centre Hospitalier Universitaire de Nice - Hôpital Pasteur 1

    Nice, 06000

  • Groupe Hospitalier Paris St Joseph - Centre Hospitalier Chartres

    Paris, 75014

    Alexandros MALLIOS Alexandros, +331 44 12 80 00, amallios@ghpsj.fr

    Alexandros MALLIOS

  • Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec

    Saint-Herblain, 44800

    Tom LE CORVEC Tom, +332 40 16 55 98, tom.lecorvec@chu-nantes.fr

    Tom LE CORVEC

Other trials in France

About this study

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

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.

Read the detailed description

Chronic kidney disease (CKD) is a global public health issue, affecting approximately 10% of the population.1,2 The number of patients starting renal replacement therapy has grown exponentially in recent years.3 Effective hemodialysis relies on a well-functioning vascular access (VA). The Kidney Disease Outcome Quality Initiative (KDOQI)4, the French Health Authority (HAS)5, and the European Society of Vascular and Endovascular Surgery (ESVS)6 recommend native arteriovenous fistulas (AVFs) as a primary option, referring to their lower morbidity, reduced mortality, and improved quality of life.7,8 An ideal AVF should allow cannulation with two needles, provide a blood flow of 300 to 600ml/min, resist infection and thrombosis, and have minimal adverse events.6 Between 2005 and 2007, 67-91% of patients in France used native AVFs.7 Data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) showed that AVF maturation varies significantly by country, patient and center characteristics. In Japan, 84% of AVFs were created in the forearm, compared to 54% in EUR/ANZ (Belgium, France, Germany, Italy, Spain, Sweden, United Kingdom, Australia, and New Zealand), and 32% in the United States (US).9 Catheter-dependence following AVF creation remained high in EUR/ANZ and US patients, with nearly 70% still dependent 8 months after AVF creation. Failure to use AVFs within 6 months was associated to a 53% higher mortality rate in the following 6 months.9 A systematic review and meta-analysis of 318 studies10 reported that average AVF primary, assisted primary and secondary patency rates at one year were 64%, 73% and 79%, respectively. However, not all patent AVFs were suitable for dialysis: only 26% were mature at 6 months, and 21% were abandoned without ever being used.

Furthermore, up to 85% of AVFs require multiple re-interventions, including angioplasty, stenting, transposition, thrombectomy or thrombolysis within the first year.11-13 On average, up to 3.43 reinterventions per patient were required over the study duration, with higher rates for brachio-basilic accesses, contributing significantly to the overall cost of care.11-13 To improve outcomes, endovascular AVF creation techniques have been developed.14 These methods use radiofrequency or thermo-coagulation energy, guided by fluoroscopy and/or duplex ultrasound. Avoiding vessel dissection and mobilization, while minimizing trauma to the vascular wall and surrounding tissues, may help reduce the risk of intimal hyperplasia and AVF failure. This approach could lead to similar benefits as those demonstrated by surgical no-touch techniques.15 Preliminary results show a technical success rate of 97.5%, a 3-month maturation rate of 89.3%, a 1-year patency rate of 85.7%, and an average of 0.59 reinterventions per patient per year.16-19 As a results, data from the United States Renal Data System (USRDS) were compared to data from the Novel Endovascular Access Trial (NEAT) and both incident and prevalent patients with endoAVF required fewer interventions and had lower costs within the first year compared with matched patients with surgical AVFs.20 However, these devices are expensive (approximately €5,200 per patient) and the creation of an endovenous fistula is not yet listed in France's common classification of medical procedures (CCAM), making it ineligible for reimbursement by health insurance.21,22 In 2019, there were 15,653 hospitalizations in France for AVF creation and re-interventions to aid AVF maturation or restore patency in patients with end-stage renal disease. Although international studies suggest that endovascular AVF creation is effective,18,20,23 no French studies have yet replicated or confirmed these findings in the local context to support reimbursement claims. The 2018 ESVS guidelines also cite a lack of evidence on endovascular AVF creation.6 This protocol represents the first French medico-economic study to compare the two available endovascular AVF creation devices - Ellipsys® (Medtronic, Dublin, Ireland) and WaveLinQ® (BD, Bard, Franklin Lakes, New Jersey, United States of America) - with traditional open surgery. This randomized clinical trial aims to provide crucial data for healthcare decision-makers, potentially paving the way for the adoption of these devices in France, enhancing patient care, and improving quality of life.

Being tested
WaveLinQ® device, Ellipsys® device, No device
Keywords
Hemodialysis, arteriovenous, endovascular, restenosis, cost-effectiveness, health economic evaluation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WaveLinQ® deviceDevice

    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® deviceDevice

    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 deviceDevice

    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 groups in NCT06679907
Study groupRoleWhat they receive
WaveLinQ® deviceExperimentalOne of the two CE-marked devices used in the Endovascular AVF arm.
Receives: Device: WaveLinQ® device
Ellipsys® deviceExperimentalOne of the two CE-marked devices used in the Endovascular AVF arm.
Receives: Device: Ellipsys® device
Open surgeryActive comparatorNot described
Receives: Device: No device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cost-utility differential ratio (expressed as cost per Quality-Adjusted Life Year [QALY]) with endovascular AVF vs. open surgery

    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.

    Measured: month 18

Secondary outcomes (39)

  1. Evaluation of total cost of care for endovascular

    This measure evaluates the total cost of care for endovascular AVF compared to surgical AVF creation at 18 and 36 months from the perspective of Mandatory Health Insurance.

    Measured: Month 18

  2. Real costs of initial hospitalization for endovascular AVF vs. surgical AVF creation

    This measure compares the real costs associated with the initial hospitalization for endovascular versus surgical AVF creation procedures.

    Measured: Day 0

  3. Evaluation of total cost of care for surgical AVF creation

    This measure evaluates the total cost of care for endovascular AVF compared to surgical AVF creation at 18 and 36 months from the perspective of Mandatory Health Insurance.

    Measured: Month 18

  4. Evaluation of total cost of care for endovascular

    This measure evaluates the total cost of care for endovascular AVF compared to surgical AVF creation at 18 and 36 months from the perspective of Mandatory Health Insurance.

    Measured: Month 36

  5. Evaluation of total cost of care for surgical AVF creation

    This measure evaluates the total cost of care for endovascular AVF compared to surgical AVF creation at 18 and 36 months from the perspective of Mandatory Health Insurance.

    Measured: Month 36

  6. Evaluation of cost functional AVF without reintervention

    This measure assesses the cost-effectiveness ratio as the cost per additional functional AVF without the need for reintervention at 36 months for WaveLinQ® or Ellipsys® devices compared to open surgery.

    Measured: Month 36

  7. Evaluation of cost with adoption of endovascular AVF

    Cost differences for health insurance over 5 years based on the adoption of endovascular techniques for AVF creation in patients requiring hemodialysis within 3-6 months or those already on dialysis in France. Data linkage between the clinical trial and the SNDS database will be performed through indirect matching using: age, postal code of residence, gender, date of hospital discharge, Diagnosis-Related Group Discharge Summary Code (GHM RSS), principal diagnosis of the stay, associated diagnoses, related diagnosis, stay number (NDA). Matching will enable continued follow-up without additional data collection, relying solely on SNIIRAM and PMSI data ensuring comprehensive tracking of AVF-related events across different care settings. Social determinants of health such as education, access to healthcare, housing stability, and socioeconomic status, will also be searched for to assess their po

    Measured: 5 years

  8. Evaluation of frequency of reinterventions for vascular access

    This measure calculates the frequency of reinterventions, including angioplasties, thrombectomies, AVF repairs, and new AVF creations, for each type of AVF creation. Data is derived from the French National Hospital Discharge Database (PMSI) and the French National Health Insurance Inter-Scheme Information System (SNIIRAM), with healthcare costs estimated from the SNDS.

    Measured: Month 36

  9. Number of AVF creation success

    This clinical endpoint measures the success rate of AVF creation. AVF creation success will be determined by the presence of a palpable "thrill" and/or confirmation of patency via immediate postoperative duplex scan.

    Measured: Day 0

  10. Number of mature AVFs

    This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.

    Measured: Month 6

  11. Number of mature AVFs

    This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.

    Measured: Month 12

  12. Number of mature AVFs

    This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.

    Measured: Month 18

  13. Evaluation of time to maturation

    This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.

    Measured: Month 6

  14. Evaluation of time to maturation

    This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.

    Measured: Month 18

  15. Evaluation of time to maturation

    This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.

    Measured: Month 12

  16. Number of Functional AVFs

    This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. AVFs functionality will be defined as a VA allowing successful cannulation with two needles over at least six hemodialysis sessions within 30 days, delivering satisfactory blood flow and achieving adequate dialysis (typically a minimum of 300 mL/min).

    Measured: Month 6

  17. Number of Functional AVFs

    This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. AVFs functionality will be defined as a VA allowing successful cannulation with two needles over at least six hemodialysis sessions within 30 days, delivering satisfactory blood flow and achieving adequate dialysis (typically a minimum of 300 mL/min).

    Measured: Month 12

  18. Number of Functional AVFs

    This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. AVFs functionality will be defined as a VA allowing successful cannulation with two needles over at least six hemodialysis sessions within 30 days, delivering satisfactory blood flow and achieving adequate dialysis (typically a minimum of 300 mL/min).

    Measured: Month 18

  19. Number of recirculation

    This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. The recirculation rate will refer to the percentage of dialyzed blood that re-enters the systemic circulation without complete clearance.

    Measured: Month 6

  20. Number of recirculation

    This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. The recirculation rate will refer to the percentage of dialyzed blood that re-enters the systemic circulation without complete clearance.

    Measured: Month 12

  21. Number of recirculation

    This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. The recirculation rate will refer to the percentage of dialyzed blood that re-enters the systemic circulation without complete clearance.

    Measured: Month 18

  22. Number of days hospitalised for AVF creation

    This measure records the average length of stay, in days, for initial hospitalization associated with AVF creation.

    Measured: Day 15

  23. Number of adverse events related to vascular access

    his measure monitors complications arising from vascular access, including limb ischemia (steal syndrome), monomelic ischemic neuropathy, high-flow conditions (blood flow > 1500 mL/min with cardiac consequences), aneurysms, hemorrhages, skin necrosis, infections, thrombosis, and AVF abandonment, with ischemia severity classified into four stages ranging from mild coldness and numbness (stage 1) to tissue loss affecting the extremities (stage 4)

    Measured: Day 1

  24. Number of adverse events related to vascular access

    his measure monitors complications arising from vascular access, including limb ischemia (steal syndrome), monomelic ischemic neuropathy, high-flow conditions (blood flow > 1500 mL/min with cardiac consequences), aneurysms, hemorrhages, skin necrosis, infections, thrombosis, and AVF abandonment, with ischemia severity classified into four stages ranging from mild coldness and numbness (stage 1) to tissue loss affecting the extremities (stage 4)

    Measured: Month 1

  25. Number of adverse events related to vascular access

    his measure monitors complications arising from vascular access, including limb ischemia (steal syndrome), monomelic ischemic neuropathy, high-flow conditions (blood flow > 1500 mL/min with cardiac consequences), aneurysms, hemorrhages, skin necrosis, infections, thrombosis, and AVF abandonment, with ischemia severity classified into four stages ranging from mild coldness and numbness (stage 1) to tissue loss affecting the extremities (stage 4)

    Measured: Month 6

  26. Number of adverse events related to vascular access

    his measure monitors complications arising from vascular access, including limb ischemia (steal syndrome), monomelic ischemic neuropathy, high-flow conditions (blood flow > 1500 mL/min with cardiac consequences), aneurysms, hemorrhages, skin necrosis, infections, thrombosis, and AVF abandonment, with ischemia severity classified into four stages ranging from mild coldness and numbness (stage 1) to tissue loss affecting the extremities (stage 4)

    Measured: Month 12

  27. Number of adverse events related to vascular access

    his measure monitors complications arising from vascular access, including limb ischemia (steal syndrome), monomelic ischemic neuropathy, high-flow conditions (blood flow > 1500 mL/min with cardiac consequences), aneurysms, hemorrhages, skin necrosis, infections, thrombosis, and AVF abandonment, with ischemia severity classified into four stages ranging from mild coldness and numbness (stage 1) to tissue loss affecting the extremities (stage 4)

    Measured: Month 18

  28. Number of serious adverse events related to AVF device

    This measure tracks serious adverse events directly related to the AVF device.

    Measured: Day 0

  29. Number of serious adverse events related to AVF device

    This measure tracks serious adverse events directly related to the AVF device.

    Measured: Month 1

  30. Number of serious adverse events related to AVF device

    This measure tracks serious adverse events directly related to the AVF device.

    Measured: Month 6

  31. Number of serious adverse events related to AVF device

    This measure tracks serious adverse events directly related to the AVF device.

    Measured: Month 12

  32. Number of serious adverse events related to AVF device

    This measure tracks serious adverse events directly related to the AVF device.

    Measured: Month 18

  33. Number of serious adverse events related to AVF device

    This measure tracks serious adverse events directly related to the AVF device.

    Measured: Month 36

  34. Number of Reinterventions related to AVF device

    This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.

    Measured: Day 0

  35. Number of Reinterventions related to AVF device

    This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.

    Measured: Month 1

  36. Number of Reinterventions related to AVF device

    This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.

    Measured: Month 6

  37. Number of Reinterventions related to AVF device

    This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.

    Measured: Month 12

  38. Number of Reinterventions related to AVF device

    This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.

    Measured: Month 18

  39. Number of Reinterventions related to AVF device

    This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.

    Measured: Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start15 Jan 2025 (estimated)
  3. Primary completion15 Jan 2030 (estimated)
  4. Study completion15 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pragmatic, comparative, unblinded, randomized, controlled, prospective, parallel-arm multicenter superiority clinical trial
Masking
None (open label)
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06679907
Sponsor's protocol ID
CHUBX 2023/49
Acronym
ENDOFAV
Status last verified
Nov 2024
First submitted
5 Nov 2024
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data is available from Pr Eric DUCASSE . An email can be sent to her so that she can contact the data manager and owner, the Bordeaux University Hospital. The data can be made available after contractual agreement.

Publications

  • Jones RG, Morgan RA. A Review of the Current Status of Percutaneous Endovascular Arteriovenous Fistula Creation for Haemodialysis Access. Cardiovasc Intervent Radiol. 2019 Jan;42(1):1-9. doi: 10.1007/s00270-018-2037-6. Epub 2018 Jul 20.

    PubMed 30030582

  • Arnold RJG, Han Y, Balakrishnan R, Layton A, Lok CE, Glickman M, Rajan DK. Comparison between Surgical and Endovascular Hemodialysis Arteriovenous Fistula Interventions and Associated Costs. J Vasc Interv Radiol. 2018 Nov;29(11):1558-1566.e2. doi: 10.1016/j.jvir.2018.05.014. Epub 2018 Oct 5.

    PubMed 30293731

  • Shahverdyan R, Beathard G, Mushtaq N, Litchfield TF, Nelson PR, Jennings WC. Comparison of Outcomes of Percutaneous Arteriovenous Fistulae Creation by Ellipsys and WavelinQ Devices. J Vasc Interv Radiol. 2020 Sep;31(9):1365-1372. doi: 10.1016/j.jvir.2020.06.008. Epub 2020 Aug 11.

    PubMed 32792280

  • Mallios A, Bourquelot P, Franco G, Hebibi H, Fonkoua H, Allouache M, Costanzo A, de Blic R, Harika G, Boura B, Jennings WC. Midterm results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System, technical recommendations, and an algorithm for maintenance. J Vasc Surg. 2020 Dec;72(6):2097-2106. doi: 10.1016/j.jvs.2020.02.048. Epub 2020 Apr 8.

    PubMed 32276012

  • Hull J, Deitrick J, Groome K. Maturation for Hemodialysis in the Ellipsys Post-Market Registry. J Vasc Interv Radiol. 2020 Sep;31(9):1373-1381. doi: 10.1016/j.jvir.2020.03.001. Epub 2020 Aug 14.

    PubMed 32800660

  • Mallios A, Jennings WC, Boura B, Costanzo A, Bourquelot P, Combes M. Early results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System. J Vasc Surg. 2018 Oct;68(4):1150-1156. doi: 10.1016/j.jvs.2018.01.036. Epub 2018 Apr 19.

    PubMed 29680297

  • Bhojani MF, Malik J, Mumtaz A, Sophie Z, Waseem S. Beyond Conventional: A Systematic Review of Non-Conventional Techniques for Radio-Cephalic Arteriovenous Fistula. Ann Vasc Surg. 2025 Jan;110(Pt B):306-316. doi: 10.1016/j.avsg.2024.07.091. Epub 2024 Aug 7.

    PubMed 39096957

  • Rajan DK, Lok CE. Promises for the future: minimally invasive fistula creation. J Vasc Access. 2015;16 Suppl 9:S40-1. doi: 10.5301/jva.5000351. Epub 2015 Mar 8.

    PubMed 25751549

  • Palmes D, Kebschull L, Schaefer RM, Pelster F, Konner K. Perforating vein fistula is superior to forearm fistula in elderly haemodialysis patients with diabetes and arterial hypertension. Nephrol Dial Transplant. 2011 Oct;26(10):3309-14. doi: 10.1093/ndt/gfr004. Epub 2011 Feb 16.

    PubMed 21325347

  • Koksoy C, Demirci RK, Balci D, Solak T, Kose SK. Brachiobasilic versus brachiocephalic arteriovenous fistula: a prospective randomized study. J Vasc Surg. 2009 Jan;49(1):171-177.e5. doi: 10.1016/j.jvs.2008.08.002. Epub 2008 Oct 22.

    PubMed 18945577

  • Woo K, Farber A, Doros G, Killeen K, Kohanzadeh S. Evaluation of the efficacy of the transposed upper arm arteriovenous fistula: a single institutional review of 190 basilic and cephalic vein transposition procedures. J Vasc Surg. 2007 Jul;46(1):94-99; discussion 100. doi: 10.1016/j.jvs.2007.02.057. Epub 2007 Jun 1.

    PubMed 17543490

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Questions about this trial

What is this clinical trial studying?

A study testing WaveLinQ® device, Ellipsys® device and No device in people with Endovascular Procedure and Hemodialysis, run by University Hospital, Bordeaux at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric DUCASSE, MD, PhD (+33556795525, eric.ducasse@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost-utility differential ratio (expressed as cost per Quality-Adjusted Life Year [QALY]) with endovascular AVF vs. open surgery (time frame: month 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06679907, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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