Comparison of Intravascular Ultrasound-Guided vs. Angiography-guided Angioplasty and Dual-antiplatelet v. Triple-antiplatelet Therapy for Outcomes of Drug-coated Balloon in the Treatment of Femoropopliteal Artery Disease (IVUS-DCB)

Yonsei University

Status

Completed

Conditions

Femoropopliteal Artery Disease

Treatments

Procedure: Angiography-guided angioplasty

Procedure: IVUS-guided angioplasty

Study type

Interventional

Funder types

Other

Identifiers

1-2015-0093

Details and patient eligibility

About

Prospective, randomized, controlled, multi-center study
A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria.
Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided intervention group.
Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional
All patients will be treated with drug-coated balloons (In.PACT Admiral) for femoropopliteal lesions.
Bare metal self-expandable stents will be used in addition according to findings of IVUS or angiography such as severity of arterial dissection or residual stenosis.
Patients will be followed clinically for 1 year after the procedure.
Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.

Enrollment

237 patients

Sex

All

Ages

19 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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%)
ABI <0.9
Patients with signed informed consent

Exclusion criteria

Acute critical limb ischemia
Severe critical limb ischemia (Rutherford category 6)
Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
Patients requiring oral anticoagulation using warfarin or NOAC
Age > 85 years
Severe hepatic dysfunction (> 3 times normal reference values)
Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
LVEF < 40% or clinically overt congestive heart failure
Pregnant women or women with potential childbearing
Life expectancy <1 year due to comorbidity
Previous bypass surgery or stenting in the target femoropopliteal artery
Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)