Impact of Aggressive Lipid-Lowering Therapy with Evolocumab on Peripheral Atherosclerotic Plaque Assessed with NIRS-IVUS in Patients with Peripheral Artery Disease
Not Applicable
Recruiting
- Conditions
- Peripheral artery disease
- Registration Number
- JPRN-UMIN000049231
- Lead Sponsor
- niversity of Fukui Division of Cardiovascular Medicine, Faculty of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
(1) patients who are pregnant or breastfeeding (2) patients for whom evolocumab therapy is contraindicated (3) patients scheduled to undergo low-density lipoprotein (LDL) apheresis (4) patients with severe liver dysfunction (such as Child-Pugh classification C)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The amount of change in max LCBI4mm from baseline to the 12-month follow-up
- Secondary Outcome Measures
Name Time Method 1)The change in lipid-core plaque distribution from baseline to the 12-month follow-up 2)The changes in total atheroma volume and percent atheroma volume from baseline to the 12-month follow-up 3)The change in minimum lumen area from baseline to the 12-month follow-up 4) Amputation-free survival at the 12-month follow-up 5) limb salvage rate at the 12-month follow-up 6) MALE (major adverse limb events) at the 12-month follow-up 7)MACE (major adverse cardiovascular events) at the 12-month follow-up 8) Revascularization rate at the 12-month follow-up