Tokyo, Oct. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059284) titled 'Prevention of the elastic recoil after balloon angioplasty for infrapopliteal zone in patients with chronic limb threateing ischemia' on Oct. 3.

Study Type: Observational

Primary Sponsor: Institute - Tokyo Bay Urayasu Ichikawa Medical Center

Condition: Condition - Chronic limb threatening ischemia (Below-the-knee) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective is to clarify the incidence of early recoil as an acute treatment outcome in cases undergoing endovascular treatment with a high-pressure balloon for popliteal artery lesions, and to explore its associated factors. We statistically examine the incidence of early recoil as an acute treatment outcome and its associated factors in cases undergoing endovascular treatment with a high-pressure balloon for popliteal artery lesions. Basic objectives2 - Safety

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients with symptomatic lower limb occlusive atherosclerosis (Rutherford classification 4-6) for whom below-knee arterial EVT is indicated 2) Patients for whom HP-POBA is determined to be the medically optimal treatment (best practice) for symptomatic atherosclerotic lesions in the below-knee arteries, and for whom HP-POBA is actually planned (Patients may also be enrolled if treatment of other arterial regions is planned concurrently) Key exclusion criteria - 1) Patients for whom limb salvage is unlikely (e.g., due to infection complications) 2) Lesions involving aneurysms in the target vessel Target Size - 150

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 03 Month 22 Day Date of IRB - 2025 Year 04 Month 25 Day Anticipated trial start date - 2025 Year 05 Month 10 Day Last follow-up date - 2030 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067794

Disclaimer: Curated by HT Syndication.