Tokyo, June 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061983) titled 'A Study Comparing Different Balloon Inflation Durations in Hemodialysis Vascular Access Treatment' on June 25.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - University of Toyama

Condition: Condition - Hemodialysis arteriovenous fistula stenosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In percutaneous transluminal angioplasty for stenosis of autogenous arteriovenous fistulas used for hemodialysis, the relationship between balloon inflation duration and postprocedural patency has not been fully established. This study aims to randomly compare balloon inflation durations of 30 and 180 seconds and to conduct an exploratory evaluation of the time to reintervention or thrombotic occlusion within 180 days after treatment, as well as procedural outcomes and safety. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Balloon angioplasty is performed for stenosis of a hemodialysis arteriovenous fistula. Balloon inflation is maintained for 30 seconds after complete disappearance of the balloon waist. If no waist is observed, inflation is maintained for 30 seconds after the prespecified inflation pressure is reached. Interventions/Control_2 - Balloon angioplasty is performed for stenosis of a hemodialysis arteriovenous fistula. Balloon inflation is maintained for 180 seconds after complete disappearance of the balloon waist. If no waist is observed, inflation is maintained for 180 seconds after the prespecified inflation pressure is reached.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Adult patients receiving maintenance hemodialysis 2. Patients with an autogenous arteriovenous fistula (AVF) 3. Patients with suspected clinical vascular access dysfunction and stenosis within the vascular access circuit for which percutaneous transluminal angioplasty is considered appropriate by an interventional radiologist 4. Patients who provide written informed consent to participate in the study Key exclusion criteria - 1. Thrombotic occlusion requiring thrombectomy, thrombolysis, or another thrombus-removal procedure 2. Stenosis or occlusion involving the axillary vein or more central veins, including the subclavian vein, brachiocephalic vein, or superior vena cava 3. Patients for whom the operator determines that the use of a cutting balloon or drug-coated balloon is clinically required during the procedure 4. Patients considered unsuitable for participation by the principal investigator because of a severely impaired general condition or other reasons Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 11 Day Date of IRB - 2026 Year 06 Month 11 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2030 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070927

Disclaimer: Curated by HT Syndication.