54
Participants
Start Date
September 19, 2022
Primary Completion Date
February 28, 2025
Study Completion Date
February 28, 2025
Selution SLR™ sirolimus-eluting balloon
If the residual stenosis is ≤30% after initial plain old balloon angioplasty, the investigators will perform angioplasty with the Selution SLR catheter, inflated at nominal pressure for at least 120 seconds. After dilatation of the entire target-lesion, biplane angiograms and IVUS imaging will be obtained. Technical success is defined as residual diameter stenosis ≤30% and adequate distal run-off. Bail-out stenting will be performed if residual stenosis is \>30%, either after plain old balloon angioplasty or angioplasty with Selution SLR. For lesions with residual stenosis \>30% but not suitable for stenting, repeat angioplasty will be performed for at most twice.
Plain old balloon angioplasty
The investigators routinely start with a balloon catheter with a diameter ≥0.5 mm smaller than the reference vessel and ended with a balloon catheter with the size approximately equal to the reference vessel diameter. Three minutes after balloon predilation, the investigators will obtain an angiogram. If the residual stenosis is ≤30%, no further intervention will be performed in the plain old balloon (POB) group.
RECRUITING
Tzung-Dau Wang, Taipei
M.A. Med Alliance S.A.
INDUSTRY
National Taiwan University Hospital
OTHER