Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060612) titled 'OptiCal frequency domain imaging-guided prospEctive AssessmeNt of severe calcified femoropopliteal lesions treated with DEBULKing device atherectomy' on March 31.
Study Type:
Observational
Primary Sponsor:
Institute - Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Condition:
Condition - Lower Extremity Artery Disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study was to exploratorily investigate factors associated with primary patency at 12 months after endovascular therapy in patients with lower extremity artery disease who had severely calcified stenotic or occlusive lesions in the femoropopliteal artery and were treated with debulking devices followed by drug coated balloon angioplasty under optical frequency domain imaging guidance, with a particular focus on the association between intraprocedural OFDI findings including the presence of calcified nodules and quantitative indices of calcification and postprocedural outcomes.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Patients with lower extremity artery disease who have severely calcified lesions in the femoropopliteal artery on angiography, defined as more than or equal to 70% diameter stenosis and classified as Peripheral Arterial Calcium Scoring System grade 3 or 4.
2) Patients who underwent elective endovascular therapy using debulking devices followed by drug-coated balloon angioplasty under optical frequency domain imaging guidance after the study approval date.
3) Patients aged 20 years or older at the time of informed consent.
4) Patients who are able to understand the treatment procedures and the objectives of the study and to provide written informed consent.
Key exclusion criteria - 1) Patients with a life expectancy of less than 1 year due to terminal illness.
2) Patients with acute limb ischemia or acute thrombosis.
3) Patients with in-stent restenosis or occlusion lesions.
4) Patients with Rutherford Category 6, or critical limb ischemia with suspected extensive infection.
5) Patients with lesions at the anastomosis site after bypass surgery.
6) Patients unable to continue antiplatelet therapy (e.g., patients scheduled for surgery requiring withdrawal of antiplatelet agents within 1 month).
7) Patients who are pregnant, breastfeeding, or possibly pregnant.
8) Other patients judged inappropriate for enrollment by the principal investigator.
Target Size - 250
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 31 Day
Anticipated trial start date - 2026 Year 05 Month 01 Day
Last follow-up date - 2030 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069115
Disclaimer: Curated by HT Syndication.
