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Disrupt CAD III With the Shockwave Coronary IVL System

NCT03595176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2023-05-19

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

Lithotripsy

Deliver Lithotripsy to the target vessel prior to placing a coronary stent.

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Dean J Kereiakes, MD,FACC,FSCAI · The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital

  • Gregg W Stone, MD,FACC,FSCAI · Columbia University

  • Jonathan Hill, MD · Royal Brompton and Harefield NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2020-05-07
Completion
2022-04-10
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • 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 NCT03595176 on ClinicalTrials.gov