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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: Completed NA study of Coronary Artery Disease and Myocardial Infarction, sponsored by Shockwave Medical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary safety endpoint was freedom from MACE at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.
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 |
What the finished NCT03595176 record still lists
NCT03595176 is an interventional study that assigns participants to a tested intervention. The registered 431 participants enrollment target is mid-sized for trials with a published cap, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (66% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03595176's enrollment target sits among peer trials
431 83rd of 219 higher than 137 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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