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NCT03595176 · ClinicalTrials.gov registry record · NA
Disrupt CAD III With the Shockwave Coronary IVL System
A NA study of Coronary Artery Disease and Myocardial Infarction, sponsored by Shockwave Medical.
- Completed
- Registry status
- NA
- Development phase
- 431
- Enrollment target
- 20
- Study locations
NCT03595176 is a NA study of Coronary Artery Disease and Myocardial Infarction that has completed, run by Shockwave Medical. The registered enrollment target is 431 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT03595176, a NA study of Coronary Artery Disease and Myocardial Infarction, has completed, sponsored by Shockwave Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 431 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DEVICE Lithotripsy
Study Locations (20)
California
- Scripps Clinic - La Jolla
- University of California, San Diego (UCSD) - Medical Center - La Jolla
- St. Joseph Hospital - Orange
- VA Palo Alto Health Care System - Palo Alto
Georgia
- Emory University Hospital Midtown - Atlanta
- Piedmont Heart Institute - Atlanta
Illinois
- Northwestern University - Chicago
- Advocate Health and Hospitals Corporation - Edward Hospital - Oakbrook Terrace
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Arizona
- Honor Health - Scottsdale
Connecticut
- Yale New Haven Hospital - New Haven
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Indiana
- St. Vincent Heart Center of Indiana, LLC - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 431 participants |
| Start Date | 2019-01-09 |
| Est. Completion | 2022-04-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03595176
The ClinicalTrials.gov registry entry for NCT03595176 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 431 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (66% lower). The listed sponsor is Shockwave Medical, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Lithotripsy is the first listed.
NCT03595176 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT03595176 about?
NCT03595176 is a clinical study titled "Disrupt CAD III With the Shockwave Coronary IVL System". 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 ...
What is the current status of trial NCT03595176?
This trial is currently completed. It is a NA study. The enrollment target is 431 participants. The study started on 2019-01-09. Estimated completion is 2022-04-10.
What conditions does trial NCT03595176 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Myocardial Infarction.
What interventions are being tested in trial NCT03595176?
The interventions under investigation include: Lithotripsy (DEVICE).
Who is sponsoring clinical trial NCT03595176?
This trial is sponsored by Shockwave Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03595176 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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