Safety & Performance of Shockwave Coronary Rx Lithoplasty® System
Research type
Research Study
Full title
Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteries
IRAS ID
196367
Contact name
Clare Huntington
Contact email
Sponsor organisation
Shockwave Medical, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This study will evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System when used to pre-treat calcified, stenotic coronary arteries prior to stenting.
The study is a prospective, single-arm, multi-centre study. Up to 60 subjects will be enrolled in the EU and Australia to undergo Coronary Rx Lithoplasty® treatment prior to coronary stent placement.
The Coronary Rx Lithoplasty® System comprises a novel combination of an angioplasty balloon with lithotripsy technology. The lithotripsy technology generates pulsatile mechanical energy within the coronary artery with the intention of disrupting calcium deposits. The disruption of calcium allows for the subsequent dilation of the artery using an angioplasty balloon at lower pressure and prior to stent placement.
It is considered that the dilation of coronary arteries using a low pressure balloon, should result in less vascular injury and thus better patient outcomes in those patients with troublesome, calcified coronary arteries.
The Shockwave Coronary Rx Lithoplasty® System is based on the same technology as the Shockwave Lithoplasty® System which is approved for the treatment of peripheral artery disease.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/0441
Date of REC Opinion
31 Mar 2016
REC opinion
Further Information Favourable Opinion