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)

* 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.

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Key information

Conditions

Femoropopliteal Artery Disease

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IVUS-guided angioplasty

Procedure

Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. IVUS evaluation will be performed before predilation and after DEB treatment. In cases of stent implantation, additional IVUS evaluation will be performed after stenting. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of IVUS measurement. Implantation of stents will be left to the operator's decision after reviewing IVUS findings after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended.

Angiography-guided angioplasty

Procedure

Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of angiogram. Implantation of stents will be left to the operator's decision after reviewing the angiogram after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended.

Primary outcomes

Procedures lesion stenosis degree

Time frame: at 12 months

Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography

Secondary outcomes

Survival free from target vessel revascularization

Time frame: 12 months

Survival free from repeat intervention or surgical treatment due to loss of patency at the target vessel

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2023
Study completion: 2023
First posted: May 8, 2018
Registry last updated: Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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