KCT0007209
Recruiting
未知
Combination therapy of Atherectomy plus drug-coated balloon versus drug-coated balloon for complex femoropopliteal artery disease
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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