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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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03517904
Study type Interventional
Source Yonsei University
Contact
Status Completed
Phase N/A
Start date May 12, 2016
Completion date October 31, 2023

See also
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