Combination therapy of Atherectomy plus drug-coated balloon versus drug-coated balloon for complex femoropopliteal artery disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007209

Enrollment

300

Registered

2022-04-19

Start date

2022-09-15

Completion date

Unknown

Last updated

2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : The target lesion in femoropopliteal artery will be treated according to the study group study subjects are randomized into.

Eligibility

Sex/Gender

All

Inclusion 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 characteristics: - long lesion (>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4) 4) Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone 5) Patients with signed informed consent

Exclusion criteria

Exclusion criteria: 1) Acute critical limb ischemia 2) Severe critical limb ischemia (Rutherford category 6) 3) Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions 4) Age > 85 years 5) Severe hepatic dysfunction (> 3 times normal reference values) 6) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis 7) LVEF < 35% or clinically overt congestive heart failure 8) Pregnant women or women with potential childbearing 9) Life expectancy <1 year due to comorbidity 10) Previous bypass surgery or stenting in the target femoropopliteal artery 11) Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

Design outcomes

Primary

Measure	Time frame
Primary patency , Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography	—

Secondary

Measure	Time frame
frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel;ankle-brachial index: ABI;Rutherford category;major adverse limb event	—

Countries

Korea, Republic of

Contacts

Public ContactYoung-Guk Ko

Yonsei University Health System, Severance Hospital

YGKO@yuhs.ac+82-2-2228-8460

Outcome results