Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions

NARecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

January 5, 2024

Primary Completion Date

December 1, 2024

Study Completion Date

March 1, 2025

Conditions
Severely Calcified Coronary StenosesDe Novo Stenosis
Interventions
PROCEDURE

Intravascular Lithotripsy

The size of the IVL balloon catheter is selected in a 1:1 ratio to the distal reference vessel diameter. The balloon catheter is then inflated to 4 atm, and 10 impulses are delivered. Subsequently, the balloon is inflated to 8 atm and then deflated to re-establish blood flow. Up to 100 impulses can be delivered, and the balloon can be repositioned within the lesion. In cases involving multiple lesions with different reference vessel diameters, various sizes of IVL balloons may be employed. If the IVL balloon catheter is unable to pass through the lesion, pre-dilatation can be performed using a smaller diameter noncompliant balloon or rotational atherectomy.

PROCEDURE

Conventional lesion preparation strategy

Conventional lesion preparation strategy includes the use of Compliant, noncompliant, cutting, or scoring balloons, Excimer laser coronary atherectomy, or Rotational atherectomy at the discretion of the operator.

Trial Locations (1)

710032

RECRUITING

Ling Tao, Xi'an

All Listed Sponsors
lead

Xijing Hospital

OTHER