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Disrupt CAD IV With the Shockwave Coronary IVL System

NCT04151628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-05-22

Study results available
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Summary

The study design is a prospective, multicenter, single-arm 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.

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

  • Gregg W Stone, MD · Columbia University

  • Shigeru Saito, MD · Shonan Kamakura General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2020-05-08
Completion
2022-03-25
FDA Device
Yes

Countries

  • Japan

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 NCT04151628 on ClinicalTrials.gov