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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)

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ClinicalTrials.gov Identifier: NCT03517904
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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.




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



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517904


Locations
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Korea, Republic of
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: YoungGuk Ko, MD    82-2-2228-8460    ygko@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03517904     History of Changes
Other Study ID Numbers: 1-2015-0093
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
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