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)

Femoropopliteal Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517904
• Other study ID #: 1-2015-0093
• Status: Completed
• Phase: N/A
• Start date: May 12, 2016
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

- 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Femoropopliteal Artery Disease

Intervention

Procedure:
• IVUS-guided angioplasty
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
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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedures lesion stenosis degree	Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography	at 12 months
Secondary	Survival free from target vessel revascularization	Survival free from repeat intervention or surgical treatment due to loss of patency at the target vessel	12 months