Tokyo, May 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061455) titled 'A Comparative Study of Thrombus Removal Treatments Using the Japanese National Clinical Database' on May 6.

Study Type: Observational

Primary Sponsor: Institute - The Japanese Society for Vascular Surgery Database Management Committee Member

Condition: Condition - Acute Limb Ischemia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to compare the safety and efficacy of surgical thrombectomy and mechanical aspiration thrombectomy for acute limb ischemia. In particular, we will evaluate whether 30-day mortality and major lower extremity amputation rates after mechanical aspiration thrombectomy are non-inferior to those after surgical thrombectomy. We will also attempt to develop a risk calculator to help determine the optimal treatment strategy for acute limb ischemia. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria will be included: Patients who underwent treatment for acute arterial occlusion of the peripheral arteries distal to the aorta between January 1, 2024, and December 31, 2024, and were registered in the National Clinical Database (NCD). Patients who underwent surgical thrombectomy or mechanical aspiration thrombectomy using the Indigo System. Age: no restriction. Sex: no restriction. Key exclusion criteria - Patients who meet any of the following criteria will be excluded from this study: Patients who decline participation in this study. Patients who are otherwise deemed unsuitable for inclusion by the principal investigator. Target Size - 3700

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 06 Month 30 Day Date of IRB - 2025 Year 06 Month 30 Day Anticipated trial start date - 2025 Year 06 Month 30 Day Last follow-up date - 2029 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070278

Disclaimer: Curated by HT Syndication.