Actively Recruiting
Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease
Led by Yonsei University · Updated on 2025-05-04
300
Participants Needed
1
Research Sites
376 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
* 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.
CONDITIONS
Official Title
Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Symptomatic peripheral artery disease with moderate or severe claudication (Rutherford category 2 or 3) or critical limb ischemia (Rutherford category 4 or 5)
- Femoropopliteal artery disease with stenosis greater than 50% and at least one complex lesion: long lesion (>150 mm), in-stent restenosis, or calcified lesion (PACSS grade 2-4)
- Lesions suitable for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
- Signed informed consent obtained from the patient
You will not qualify if you...
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Allergy or contraindication to heparin, aspirin, clopidogrel, or contrast agents
- Age over 85 years
- Severe liver dysfunction (more than 3 times normal reference values)
- Significant thrombocytopenia, anemia, or known bleeding disorders
- Left ventricular ejection fraction less than 35% or overt congestive heart failure
- Pregnant women or women with potential for pregnancy
- Life expectancy less than 1 year due to other illnesses
- Previous bypass surgery in the target femoropopliteal artery
- Untreated inflow disease in the same leg's pelvic or femoropopliteal arteries with more than 50% stenosis or occlusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
Y
Young-Guk Ko, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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