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NCT05966662 · ClinicalTrials.gov registry record · NA
Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)
A NA study of Coronary Artery Disease and Myocardial Infarction, sponsored by Shockwave Medical.
- Completed
- Registry status
- NA
- Development phase
- 145
- Enrollment target
- 18
- Study locations
NCT05966662 is a NA study of Coronary Artery Disease and Myocardial Infarction that has completed, run by Shockwave Medical. The registered enrollment target is 145 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (89% lower). The trial reports 18 study locations across 15 states.
The verdict
NCT05966662, a NA study of Coronary Artery Disease and Myocardial Infarction, has completed, sponsored by Shockwave Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 145 participants
- Enrollment target
- 18
- Study locations
Study Summary
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.
Conditions Studied
Interventions
- DEVICE IVL with Shockwave C2+ 2Hz Coronary IVL Catheter
Study Locations (18)
New York
- Northwell Health/Lenox Hill - New York
- St. Francis Hospital - Roslyn
Pennsylvania
- UPMC Pinnacle Health - Harrisburg
- WellSpan Health - York - York
Texas
- Baylor Scott and White Research Institute - Dallas
- Methodist Hospital - San Antonio
Alabama
- Heart Center Research - Huntsville
California
- Scripps Clinic - La Jolla
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Florida
- Memorial Health - Hollywood
Georgia
- Wellstar Kennestone Hospital - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2023-12-08 |
| Est. Completion | 2025-12-19 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05966662
The ClinicalTrials.gov registry entry for NCT05966662 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (89% 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 IVL with Shockwave C2+ 2Hz Coronary IVL Catheter is the first listed.
NCT05966662 reports 18 study locations spanning 15 distinct geographic areas - top geographies include New York, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT05966662 about?
NCT05966662 is a clinical study titled "Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)". This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.
What is the current status of trial NCT05966662?
This trial is currently completed. It is a NA study. The enrollment target is 145 participants. The study started on 2023-12-08. Estimated completion is 2025-12-19.
What conditions does trial NCT05966662 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Myocardial Infarction.
What interventions are being tested in trial NCT05966662?
The interventions under investigation include: IVL with Shockwave C2+ 2Hz Coronary IVL Catheter (DEVICE).
Who is sponsoring clinical trial NCT05966662?
This trial is sponsored by Shockwave Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05966662 being conducted?
This trial has 18 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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