Microcirculatory Status After Intravascular Lithotripsy

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 6, 2020

Primary Completion Date

December 1, 2021

Study Completion Date

December 31, 2021

Conditions
Chronic Coronary InsufficiencyCoronary Artery Disease
Interventions
DEVICE

Shockwave® Intravascular Lithotripsy System (Shockwave Medical Inc)

IVL is a novel balloon catheter-based device that utilises pulsatile mechanical energy to disrupt calcified lesions. IVL differs from other types of lithotripsy with respect to depth of penetration. It is a single-use, sterile, disposable balloon catheter. The emitters convert electrical energy into transient acoustic circumferential pressure pulses that disrupt both superficial and deep calcium within plaque. The balloon catheter is connected to the generator, which is programmed to deliver the specified dosage of pulses. The IVL balloon, sized 1:1 to the reference artery ratio, is inflated low pressure (4 atm) with 10 pulses of ultrasound energy of 10s delivered per balloon. The procedure is repeated to provide a minimum of 20 pulses in the target lesion, with interval deflation to allow distal perfusion. Each catheter can emit a max of 80 pulses at a rate of one pulse per second. If the lesion exceeds the 12mm balloon length, the balloon can be repositioned and the IVL repeated.

Trial Locations (1)

28040

Hospital San Carlos, Madrid

Sponsors
All Listed Sponsors
lead

Cardiac Research Institute BV

OTHER