Pemafibrate Research to evaluate effect on lower Extremity Vessel lumen after lower Extremity eNdovascular Treatment with drug-coated balloon in patients with hypertriglyceridemia complicated with Lower Extremity Artery Disease; multicenter, prospective, open-label, randomized-controlled trial (PREVENT-LEAD study)

Recruitment & Eligibility

Inclusion Criteria

Patients who meet all of the following criteria are included in this study;

male and female aged 18 years or older and 85 years or younger at giving their consent
patients who have been planed to receive endovascular treatment (EVT) for lower extremity arteriosclerosis obliterans at site/institution that implements this study
patients with lower extremity arteriosclerosis obliterans of Fontaine classification II or lower
patients with TASC classification A or B by image or ultrasonography
patients whose fasting TG was controlled to be 150mg/dL or higher and less than 500mg/dL, or whose casual TG was controlled to be 175mg/dL or higher and less than 500mg/dL throughout 12 weeks before giving their consent
patients whose LDL-chol was controlled to be less than 100mg/dL throughout 12 weeks before giving their consent
patients with Clinically Frailty Score (CFS) of 7 or lower
patients who give their consent in written form from themselves by their free wil

Exclusion Criteria

Patients who fall into any of the following criteria are excluded from participating in the study;

patients whose life expectancy is considered to be less than 1 year due to other complications
patients with history of allegy to pemafibrate or who meet contraindication of pemafibrate
patients with eGFR of less than 30ml/min/1.73m2 at giving their consent, or patient with maintenance dialysis
patients with extensive gangrene/ulceration that is judged to require early amputation intervention
patients with complications of serious infection that are deemed to require early debridement or toe amputation intervention
patients requiring treatment (chemotherapy, radiation therapy, surgery, etc.) for active malignant neoplasms
patients who are judged to be poor adherence by the responsible investigator or subinvestigators
patients who need regal representatives to give their consent
patients with other conditions that the responsible investigator or subinvestigators judge inappropriate to participate in the study

Study & Design

Primary Outcome Measures

Name	Time	Method
-		Change in minimum lumen area (MLA) from EVT implementation to week 52

Secondary Outcome Measures

Name	Time	Method
Change in fasting TG and remnant cholesterol		Change in fasting TG and remnant cholesterol
presence or absence, or duration of revascularization for the subject limb		presence or absence, or duration of revascularization for the subject limb
change in plaque volume (deltaTAV) in 2.5 cm before and after the MLA site in the treated area by IVUS		change in plaque volume (deltaTAV) in 2.5 cm before and after the MLA site in the treated area by IVUS, change in lumen vascularis, and change in blood vessel diameter at the MLA site
change in MLA in non-treated area in the femoral popliteal artery region within the range of IVUS observation		change in MLA in non-treated area in the femoral popliteal artery region within the range of IVUS observation
presence or absence of new ulcer development in the subject or non-subject limbs		presence or absence of new ulcer development in the subject or non-subject limbs
patency rate (PSVR of 2.4 or higher by lower extremity echography)		patency rate (PSVR of 2.4 or higher by lower extremity echography)
change in general blood tests		change in general blood tests (serum LDL-chol, serum HDL-chol, Fibrinogen, D-dimer, CRP, eGFR, VLDL-C, apolipoprotein C-III, apolipoprotein B)
change in special blood test (blood sedimentation)		change in special blood test (blood sedimentation)

Recruitment & Eligibility