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Be Part of Research - Trial Details - Disrupt CAD III With the Shockwave Coronary IVL System
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Disrupt CAD III With the Shockwave Coronary IVL System

Completed

Open to: ALL

Age: All

London Clydebank London

Medical Conditions

Coronary Artery Disease
Myocardial Infarction
Infarction

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jan 2019 May 2020

Publications

"Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15."; "33069849"; "Kereiakes DJ, Hill JM, Ben-Yehuda O, Maehara A, Alexander B, Stone GW. Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. Am Heart J. 2020 Jul;225:10-18. doi: 10.1016/j.ahj.2020.04.005. Epub 2020 Apr 18."; "32470635"; "Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3."; "33939604"

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : Deliver Lithotripsy to the target vessel prior to placing a coronary stent.

Intervention Arm Group : Coronary Lithotripsy System;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • King's College Hospital
    London
    SE5 9RS
  • Golden Jubilee National Hospital
    Clydebank
    G81 4DY
  • St. Bartholomew's Hospital
    London
    EC1A 7BE


The study is sponsored by Shockwave Medical, Inc.



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Read full details for Trial ID: NCT03595176
Last updated 17 May 2023

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