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Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)

NCT03328949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-11-19

Study results available
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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.

Conditions

Interventions

DEVICE

IVL Coronary Lithotripsy System

The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Jean Fajadet, MD · Clinic Pasteur

  • Carlo DiMario, MD · University of Florence

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-18
Primary Completion
2019-03-26
Completion
2019-04-25

Countries

  • Belgium
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03328949 on ClinicalTrials.gov