Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease

Recruiting now · Not applicable

Conditions studied: Femoropopliteal Artery Disease

In brief

* 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 criteria. Complex lesions include long lesions (\>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions. * Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year. * Patients will be followed clinically for 2 years after the procedure.

Key facts

Study ID

NCT05307263

Run by

Yonsei University

People needed

300

Starts

2022-09-15

Expected to finish

2029-12-01

Last updated by the study team

2025-05-04

Who can join

Age: 19 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Yonsei University Health System, Severance Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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