Combination therapy of Atherectomy plus drug-coated balloon versus drug-coated balloon for complex femoropopliteal artery disease

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0007209

Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

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%) with one of following complex lesion characteristics: - long lesion (>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4)
4) Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
5) Patients with signed informed consent

Exclusion Criteria

1) Acute critical limb ischemia
2) Severe critical limb ischemia (Rutherford category 6)
3) Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
4) Age > 85 years
5) Severe hepatic dysfunction (> 3 times normal reference values)
6) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
7) LVEF < 35% or clinically overt congestive heart failure
8) Pregnant women or women with potential childbearing
9) Life expectancy <1 year due to comorbidity
10) Previous bypass surgery or stenting in the target femoropopliteal artery
11) 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
frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel;ankle-brachial index: ABI;Rutherford category;major adverse limb event