Tokyo, Feb. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060656) titled 'BEETLE' on Feb. 12.
Study Type:
Observational
Primary Sponsor:
Institute - Asahi General Hospital
Condition:
Condition - DCB: Drug Coated Balloon
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the clinical outcomes of DCB monotherapy for lesions with longer lesion lengths or occlusion lengths, previously classified as TASC II C/D lesions, and to explore the morphological characteristics of these lesions associated with clinical outcomes.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Age 20 years or older
2) Patients with symptomatic lower extremity peripheral arterial disease (Rutherford classification 2-5)
3) Lesions present from the superficial femoral artery to the distal popliteal artery
4) Femoral-popliteal artery lesions corresponding to TASC II C/D
5) Use of a drug-coated balloon (DCB) as the final device to fully cover the lesion
Key exclusion criteria - 1) Lesions involving aneurysms in target vessels
2) Expected survival period of 12 months or less
3) Cases of stent restenosis
4) Cases of acute lower extremity arterial occlusion
5) Cases where a debulking device is planned for use
6) Cases where provisional stent placement is planned
Target Size - 300
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 06 Month 30 Day
Date of IRB - 2025 Year 07 Month 15 Day
Anticipated trial start date - 2025 Year 11 Month 04 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069380
Disclaimer: Curated by HT Syndication.
