Clinical Trial: A randomized clinical trial evaluating the effect of pre-dilatation with a cutting balloon prior to drug-coated balloon angioplasty (Japan)

Tokyo, Sept. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059132) titled 'A randomized clinical trial evaluating the effect of pre-dilatation with a cutting balloon prior to drug-coated balloon angioplasty' on Sept. 24.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Shizuoka General Hospital

Condition: Condition - End-stage renal disease, hemodialysis vascular access stenosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Patients undergoing hemodialysis require reliable vascular access, and the maintenance of arteriovenous:AV access is essential for the continuation of hemodialysis therapy. When AV access stenosis occurs, percutaneous transluminal angioplasty:PTA is the first-line option. Although the clinical success rate of PTA is high, the patency of PTA is relatively low. Recently, drug coated balloons:DCBs have become available for vascular access stenosis, particularly for patients with early restenosis. Nevertheless, restenosis still occurs in some cases even after DCB angioplasty. In the cardiovascular field, complete lesion preparation prior to DCB deployment often using cutting or scoring balloons is considered critical for optimal outcomes. Such pre dilatation strategies are recommended, yet in the context of vascular access, current treatment guidelines do not specify balloon selection, and supporting evidence remains limited. Meanwhile, clinical studies on cutting balloons used for AV access stenosis have demonstrated superior dilatation efficacy compared to conventional balloons. If this randomized trial confirms the utility of cutting balloon pre-dilatation prior to DCB use, it may lead to prolonged patency and enhanced therapeutic efficacy of DCBs in vascular access interventions. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - intervention: pre-dilatation with a cutting balloon prior to drug-coated balloon angioplasty Interventions/Control_2 - control: pre-dilatation with a conventional balloon prior to drug-coated balloon angioplasty

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Age more than 20 years 2. AV fistula created at least 30 days prior to enrollment 3. At least 8 out of the most recent 12 dialysis sessions were completed without complications 4. Presence of more than 50% stenosis from the anastomosis site to the axillary vein or subclavian vein entry 5. In cases with two stenotic lesions, both must be treatable with a single drug-coated balloon 6. For tandem lesions, the distance between lesions must be within 3 cm 7. Reference vessel diameter at the target lesion must be between 4 mm and 8 mm 8. Written informed consent obtained based on sufficient understanding and voluntary agreement to participate in the study 9. Ability to attend follow up visits after treatment 10. Both de novo and restenotic lesions are eligible for inclusion Key exclusion criteria - 1. Women who are pregnant, breastfeeding, or planning to become pregnant, and men who wish to father children 2. Scheduled to undergo kidney transplantation within 6 months 3. Planned transition to peritoneal dialysis within 6 months 4. Underwent vascular intervention for access within the past 30 days 5. Presence of severe AV access infection or systemic infection contraindicating PTA 6. Scheduled for surgical revision of the AV access within 6 months 7. Presence of secondary lesions requiring additional treatment within 30 days 8. Severe ischemia of the limb contraindicating PTA 9. Presence of advanced malignancy or systemic infection with an expected life expectancy of less than 6 months 10. Moderate to severe vessel tortuosity at the target site that precludes the use of a cutting balloon 11. Presence of visible thrombus at the target lesion that contraindicates the use of a drug coated balloon 12. Presence of a stent at the stenotic site Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 01 Day Date of IRB - 2025 Year 07 Month 22 Day Anticipated trial start date - 2025 Year 09 Month 24 Day Last follow-up date - 2031 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067636

Disclaimer: Curated by HT Syndication.