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

NCT06679907 | Not Yet Recruiting

• 1 other identifier: CHUBX 2023/49
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Endovascular Procedure; Hemodialysis

Keywords

Hemodialysis; arteriovenous; endovascular; restenosis; cost-effectiveness; health economic evaluation

Outcome Measures

Primary Outcomes (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.

  month 18

Secondary Outcomes (39)

• Evaluation of total cost of care for endovascular

  Month 18

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

  Day 0

• Evaluation of total cost of care for surgical AVF creation

  Month 18

• Evaluation of total cost of care for endovascular

  Month 36

• Evaluation of total cost of care for surgical AVF creation

  Month 36

Study Arms (3)

WaveLinQ® device

EXPERIMENTAL

One of the two CE-marked devices used in the Endovascular AVF arm.

Device: WaveLinQ® device

Ellipsys® device

EXPERIMENTAL

One of the two CE-marked devices used in the Endovascular AVF arm.

Device: Ellipsys® device

Open surgery

ACTIVE COMPARATOR

Device: No device

Interventions

WaveLinQ® device 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.

WaveLinQ® device

Ellipsys® device 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.

Ellipsys® device

No device 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.

Open surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (11)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

Location

Polyclinique Bordeaux Nord Aquitaine - Centre Aquitain des pathologies vasculaire

Bordeaux, 33200, France

Location

AP-HP Centre Hospitalier Universitaire d'Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Clinique du parc

Castelnau-le-Lez, 34170, France

Location

Centre Hospitalier Universitaire de Dijon - Hôpital le Bocage

Dijon, 21000, France

Location

Centre Hospitalier Mutualiste de Grenoble

Grenoble, 38000, France

Location

Hôpital privé Jean Mermoz

Lyon, 69000, France

Location

Centre Hospitalier St Joseph - St Luc

Lyon, 69007, France

Location

Centre Hospitalier Universitaire de Nice - Hôpital Pasteur 1

Nice, 06000, France

Location

Groupe Hospitalier Paris St Joseph - Centre Hospitalier Chartres

Paris, 75014, France

Location

Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec

Saint-Herblain, 44800, France

Location

Related Publications (20)

• 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.

  PMID: 30030582 BACKGROUND

• 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.

  PMID: 30293731 BACKGROUND

• 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.

  PMID: 32792280 BACKGROUND

• 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.

  PMID: 32276012 BACKGROUND

• 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.

  PMID: 32800660 BACKGROUND

• 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.

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• 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.

  PMID: 39096957 BACKGROUND

• 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.

  PMID: 25751549 BACKGROUND

• 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.

  PMID: 21325347 BACKGROUND

• 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.

  PMID: 18945577 BACKGROUND

• 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.

  PMID: 17543490 BACKGROUND

• Bylsma LC, Gage SM, Reichert H, Dahl SLM, Lawson JH. Arteriovenous Fistulae for Haemodialysis: A Systematic Review and Meta-analysis of Efficacy and Safety Outcomes. Eur J Vasc Endovasc Surg. 2017 Oct;54(4):513-522. doi: 10.1016/j.ejvs.2017.06.024. Epub 2017 Aug 23.

  PMID: 28843984 BACKGROUND

• Pisoni RL, Zepel L, Zhao J, Burke S, Lok CE, Woodside KJ, Wasse H, Kawanishi H, Schaubel DE, Zee J, Robinson BM. International Comparisons of Native Arteriovenous Fistula Patency and Time to Becoming Catheter-Free: Findings From the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2021 Feb;77(2):245-254. doi: 10.1053/j.ajkd.2020.06.020. Epub 2020 Sep 21.

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• Ravani P, Palmer SC, Oliver MJ, Quinn RR, MacRae JM, Tai DJ, Pannu NI, Thomas C, Hemmelgarn BR, Craig JC, Manns B, Tonelli M, Strippoli GF, James MT. Associations between hemodialysis access type and clinical outcomes: a systematic review. J Am Soc Nephrol. 2013 Feb;24(3):465-73. doi: 10.1681/ASN.2012070643. Epub 2013 Feb 21.

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• Ethier J, Mendelssohn DC, Elder SJ, Hasegawa T, Akizawa T, Akiba T, Canaud BJ, Pisoni RL. Vascular access use and outcomes: an international perspective from the Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant. 2008 Oct;23(10):3219-26. doi: 10.1093/ndt/gfn261. Epub 2008 May 29.

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Central Study Contacts

Eric DUCASSE, MD, PhD

CONTACT

+33556795525; eric.ducasse@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, comparative, unblinded, randomized, controlled, prospective, parallel-arm multicenter superiority clinical trial

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 15, 2030
• Study Completion (Estimated): January 15, 2030
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

FR (11)