Can the use of a VasQ external support device improve the maturation and utilization of wrist distal arteriovenous fistulas?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: Patients with terminal renal insufficiency that have been proposed for a creation of a distal arteriovenous fistulae (radiocephalic) in the arm, will be randomized using simple randomization to the creation of a conventional distal fistula or with the placement of the VasQ device (external support intended to improve fistulae maturation and utilization). The maturation (primary objective), patency and usefulness of the accesses will be analyzed for 1 year after their creation, comparing both groups. CONDITION: Maturation and utilization of distal radial‐cephalic arteriovenous fistulae for hemodialysis ; Urological and Genital Diseases PRIMARY OUTCOME: The percentage of maturation of radiocephalic arteriovenous fistulas after 1 year of its creation. A fistula is considered mature when is suitable to be punctured for hemodialysis sessions, after a specialized nurse or medical evaluation or ultrasound measurements, following the European Society for Vascular Surgery (ESVS) and Kidney Disease Outcomes Quality Initiative (KDOQUI) guideline definitions SECONDARY OUTCOME: ; 1. Primary patency (PP), assisted primary patency (PA) and secondary patency (PS) at 1 year of follow‐up; 2. The use of these accesses in those patients in the hemodialysis program:; 2.1. PP will be considered the patency of the vascular access until its first: open or endovascular procedure to avoid its occlusion; open or endovascular procedure to declot it; definitive thrombosis or occlusion (time from creation to any procedure to prevent thrombosis, treat thrombosis, or definitive thrombosis); 2.2. Assisted PA will be considered the patency of the vascular access until its first: open or endovascular procedure to declot it; definitive thrombosis or occlusion (time from creation to any procedure to treat thrombosis, or definitive thrombosis); 2.3. PS will be considered the patency of the vascular access until its definitive thrombosis or definite (time from creation to definitive thrombosis); INCLUSION CRITERIA: 1. Patients with chronic renal failure stages 5 and 5D (renal failure in the pre‐dialysis stage or in a hemodialysis program), candidates according to usual clinical practice for the creation of a radiocephalic (distal) arteriovenous fistula for hemodialysis 2. Adults (18 years or older), who understand the study and agree to participate in it 3. In the arm proposed for the creation of access (after evaluation of both and patient preference): distal cephalic vein after proximal tourniquet between 2 and 6 mm in diameter, patent, without significant stenosis, with continuity through the forearm and good connection with the deep venous system (by perforating elbow, cephalic or proximal basilic vein), less than 6 mm deep (ultrasound examination) 4. Radial artery of the same extremity, between 2 and 6 mm in diameter, with a distal triphasic curve (normal) and good radial pulse, without mural calcification or occlusion 5. Absence of isc
Epistemonikos ID: fe25c2087ba0b512cd10790cf033a658815df5c1
First added on: Feb 20, 2024