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

Recruiting N/A Interventional Study
Femoropopliteal Artery Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
19 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Yonsei University · Other
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About This Trial
* 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 (D…
Trial Locations
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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…
Contacts

Young-Guk Ko, MD, PhD

82-2-2228-8460

ygko@yuhs.ac

CONTACT