DISRUPT CAD II POST-MARKET STUDY (Version number B - 29 Nov 2017)
Research type
Research Study
Full title
Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries.
IRAS ID
240410
Contact name
Jonathan Hill
Contact email
Sponsor organisation
Shockwave Medical, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
This study is a Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries. The purpose of this study is to examine the safety and performance of a new device called the Shockwave Coronary Lithoplasty System that has been developed by Shockwave Medical Inc. for the treatment of narrowed coronary arteries. The new treatment is called coronary lithoplasty. The Shockwave Medical Coronary Lithoplasty System is an approved device. This means it has received CE marked. Up to 15 centers in Western Europe will participate in this study. Up to 120 patients will be enrolled in total for this study.
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/0326
Date of REC Opinion
23 Apr 2018
REC opinion
Further Information Favourable Opinion