200
Participants
Start Date
January 29, 2020
Primary Completion Date
September 1, 2024
Study Completion Date
November 1, 2025
Lithoplasty
"The lithoplasty balloon should be utilized as early as possible. If it is necessary for passage of the lithoplasty balloon, the lesion may first be predilated with an undersized conventional balloon, non-compliant or semi-compliant. If passage of the lithoplasty balloon is still not possible, it is recommended to perform rotational atherectomy with a small burr size.~The lithoplasty balloon is sized 1:1 to reference diameter. Lithoplasty is performed with the balloon dilated at 4 atmospheres, and 10 shocks are delivered, after which the balloon is expanded to 6 atmospheres for 30 seconds, and then deflated. Up to 8 series of balloon expansion/deflation can be delivered in this manner if necessary, and several balloons may be used for long lesions."
Conventional
Lesion preparation is performed starting with conventional balloons, non-compliant or semi-compliant. Unless fully satisfactory dilatation is achieved with conventional balloons, it is recommended to also use modified balloons (scoring balloons, cutting balloons). If balloons cannot be passed or if dilatation is inadequate, the lesion may first be predilated with an undersized conventional, non-compliant, or semi-compliant balloon. If necessary, rotational atherectomy with a small burr size can be used to facilitate adequate balloon preparation.
Rigshospitalet, Copenhagen
Gentofte University Hospital, Gentofte Municipality
Zealand University Hospital, Roskilde Sygehus, Roskilde
Odense University Hospital, Odense
Aarhus University Hospital Skejby, Aarhus
Aalborg University Hospital, Aalborg
University Hospital Leuven, Leuven
North-Estonia Medical Center, Tallinn
Trondheim University Hospital, Trondheim
Collaborators (1)
Abbott
INDUSTRY
Shockwave Medical, Inc.
INDUSTRY
Herlev and Gentofte Hospital
OTHER