Comparison of Three Types of Distal Arteriovenous Fistulas: SBAVF, RCAVF, and RCAVF With Venous Branch Patch.

NCT06550479 | Recruiting

• 1 other identifier: WMU
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine which type of distal arteriovenous fistula (SBAVF, RCAVF, and RCAVF with venous branch patch) is most clinically favorable. The recommendations and scientific evidence do not suggest which option should be chosen initially. The investigators expect that results will show which type of the anastomosis should be preferred.

Conditions

Dialysis; Complications; Vascular Access Complication

Outcome Measures

Primary Outcomes (3)

• Primary patency:

  The interval between VA creation and the first re-intervention (intervention free VA survival) for VA dysfunction or thrombosis, the time of measurement of patency or the time of its abandonment

  12 months

• Assisted primary patency:

  The interval between VA creation and the first occlusion (thrombosis free VA survival) or measurement of patency including operative/endovascular interventions to maintain the VA.

  36 months

• Secondary patency

  The interval between VA creation and the abandonment of this VA (i.e. thrombosis) after one or more interventions or the time of measurement of patency including achievement of a censored event (death, change of HD modality, loss of follow-up).

  36 months

Secondary Outcomes (1)

• Mature VA

  6 weeks

Study Arms (3)

SBAVF

EXPERIMENTAL

Patients enrolled for snuffbox fistula creation.

Procedure: AVF

RCAVF

EXPERIMENTAL

Patients enrolled for RCAVF

Procedure: AVF

RCAVF with venous branch patch

EXPERIMENTAL

Patients enrolled for RCAVF with venous branch patch

Procedure: AVF

Interventions

AVF PROCEDURE

Distal forearm AVF for hemodialysis.

RCAVF; RCAVF with venous branch patch; SBAVF

Eligibility Criteria

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

You may qualify if:

• Aged \>18 years
• Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73 m2

You may not qualify if:

• Heart failure of New York Heart Association functional class III or IV,
• Episode of cardio- or cerebrovascular event or receiving intervention therapy within 3 months prior to screening.
• The patient had the primary anastomosis in the past on ipsilateral extremity

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Department of Nephrology and Transplantation Medicine

Wroclaw, 50-556, Poland

RECRUITING

Related Publications (6)

• Tordoir J, Canaud B, Haage P, Konner K, Basci A, Fouque D, Kooman J, Martin-Malo A, Pedrini L, Pizzarelli F, Tattersall J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG on Vascular Access. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii88-117. doi: 10.1093/ndt/gfm021. No abstract available.

  PMID: 17507428 RESULT

• Roy-Chaudhury P, Kelly BS, Melhem M, Zhang J, Li J, Desai P, Munda R, Heffelfinger SC. Vascular access in hemodialysis: issues, management, and emerging concepts. Cardiol Clin. 2005 Aug;23(3):249-73. doi: 10.1016/j.ccl.2005.04.004.

  PMID: 16084276 RESULT

• Stoner L, Sabatier MJ. Use of ultrasound for non-invasive assessment of flow-mediated dilation. J Atheroscler Thromb. 2012;19(5):407-21. doi: 10.5551/jat.11395. Epub 2012 Mar 1.

  PMID: 22659525 RESULT

• Jemcov TK. Morphologic and functional vessels characteristics assessed by ultrasonography for prediction of radiocephalic fistula maturation. J Vasc Access. 2013 Oct-Dec;14(4):356-63. doi: 10.5301/jva.5000163. Epub 2013 Jul 1.

  PMID: 23817950 RESULT

• 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 RESULT

• Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM. Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30.

  PMID: 24183112 RESULT

Study Design

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

Model Details: Comparison of three different distal AVF types

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 13, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2030
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)