Comparison of intravascular ultrasound–guided vs. angiography-guided angioplasty and dual-antiplatelet v. triple-antiplatelet therapy for outcomes of drug-coated balloon in the treatment of femoropopliteal Artery disease (IVUS-DCB)
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
1) Age 19 years or older
2) Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5)
3) Femoropopliteal artery disease (stenosis > 50%)
4) ABI <0.9
5) Patients with signed informed consent
1) Acute critical limb ischemia
2) Severe critical limb ischemia (Rutherford category 6)
3) Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
4) Patients requiring oral anticoagulation using warfarin or NOAC
5) Age > 85 years
6) Severe hepatic dysfunction (> 3 times normal reference values)
7) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
8) LVEF < 40% or clinically overt congestive heart failure
9) Pregnant women or women with potential childbearing
10) Life expectancy <1 year due to comorbidity
11) Previous bypass surgery or stenting in the target femoropopliteal artery
12) Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary patency , Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography
- Secondary Outcome Measures
Name Time Method ankle-brachial index;Rutherford category;frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel;Salvage of Target vessel