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.
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