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

ConditionsDialysis; ComplicationsVascular Access Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWroclaw Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged >18 years

Chronic kidney disease with estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AVF

    Procedure/Surgery

    Distal forearm AVF for hemodialysis.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: SBAVFExperimental treatment 1 intervention
Group B: RCAVFExperimental treatment 1 intervention
Group C: RCAVF with venous branch patchExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 months
2

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.

Time frame
36 months
3

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).

Time frame
36 months

Secondary outcomes

1

Mature VA

A fistula was considered mature when the blood flow exceeded 500 ml/min and the diameter of the cephalic vein exceeded 5 mm.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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Wroclaw Medical University

Lead sponsor

Source ClinicalTrials.gov
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