Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions

NAActive, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

January 29, 2020

Primary Completion Date

September 1, 2024

Study Completion Date

November 1, 2025

Conditions
Percutaneous Coronary InterventionCoronary Artery CalcificationCoronary Artery Disease
Interventions
DEVICE

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."

DEVICE

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.

Trial Locations (9)

2100

Rigshospitalet, Copenhagen

2900

Gentofte University Hospital, Gentofte Municipality

4000

Zealand University Hospital, Roskilde Sygehus, Roskilde

5000

Odense University Hospital, Odense

8200

Aarhus University Hospital Skejby, Aarhus

9100

Aalborg University Hospital, Aalborg

Unknown

University Hospital Leuven, Leuven

North-Estonia Medical Center, Tallinn

Trondheim University Hospital, Trondheim

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

collaborator

Shockwave Medical, Inc.

INDUSTRY

lead

Herlev and Gentofte Hospital

OTHER