Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)

Status Completed

Clinical Trial Summary

The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.

Clinical Trial Description

The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure.

Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit. ;

Study Design

Related Conditions & MeSH terms

Coronary Artery Disease

Clinical Trial Details

NCT number	NCT03328949
Study type	Interventional
Source	Shockwave Medical, Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 18, 2018
Completion date	April 25, 2019

View Details

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