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)

  • STATUS
    Recruiting
  • participants needed
    240
  • sponsor
    Yonsei University
Updated on 12 April 2021

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.

Details
Condition Femoropopliteal Artery Disease
Treatment IVUS-guided angioplasty, Angiography-guided angioplasty
Clinical Study IdentifierNCT03517904
SponsorYonsei University
Last Modified on12 April 2021

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