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)

• ClinicalTrials.gov Identifier: NCT03517904
• Recruitment Status: Completed
• First Posted: May 8, 2018
• Last Update Posted: December 5, 2023
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Femoropopliteal Artery Disease	Procedure: IVUS-guided angioplasty; Procedure: Angiography-guided angioplasty	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 237 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: May 12, 2016
• Actual Primary Completion Date: October 31, 2023
• Actual Study Completion Date: October 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: IVUS-guided group; Intravascular ultrasound-guided intervention group	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.
Active Comparator: Angiography-guided group; Angiography-guided intervention group	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. Procedures lesion stenosis degree [ Time Frame: at 12 months ]
   Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

Korea, Republic of

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

Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Yonsei University

More Information

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT03517904
• Other Study ID Numbers: 1-2015-0093
• First Posted: May 8, 2018
• Last Update Posted: December 5, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Yonsei University:

Femoropopliteal artery disease, drug-coated balloon, angioplasty, antiplatelet therapy