Status:
RECRUITING
Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease
Lead Sponsor:
Yonsei University
Conditions:
Femoropopliteal Artery Disease
Eligibility:
All Genders
19-85 years
Phase:
NA
Brief Summary
* Prospective, multi-center, randomized, controlled comparison study * A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteri...
Eligibility Criteria
Inclusion
- Age 19 years or older
- Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5)
- 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)
- Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
- Patients with signed informed consent
Exclusion
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
- Age \> 85 years
- Severe hepatic dysfunction (\> 3 times normal reference values)
- Significant thrombocytopenia, anemia, or known bleeding diathesis
- LVEF \< 35% or clinically overt congestive heart failure
- Pregnant women or women with potential childbearing
- Life expectancy \<1 year due to comorbidity
- Previous bypass surgery in the target femoropopliteal artery
- Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
Key Trial Info
Start Date :
September 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05307263
Start Date
September 15 2022
End Date
December 1 2029
Last Update
May 4 2025
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea