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NCT06662500 · ClinicalTrials.gov registry record · NA
FORWARD CAD IDE Study
A NA study of Coronary Arterial Disease (CAD), sponsored by Shockwave Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 408
- Enrollment target
- 20
- Study locations
NCT06662500: Recruiting NA study of Coronary Arterial Disease (CAD), sponsored by Shockwave Medical.
NCT06662500 is a NA study of Coronary Arterial Disease (CAD) that is actively recruiting participants, run by Shockwave Medical. The registered enrollment target is 408 participants, below the 2,997-participant average among 5 other Coronary Arterial Disease (CAD) trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06662500, a NA study of Coronary Arterial Disease (CAD), is actively recruiting participants, sponsored by Shockwave Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 408 participants
- Enrollment target
- 20
- Study locations
Study Summary
The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic de novo coronary artery lesions prior to stenting.
Primary Outcome
Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure. MACE (Clinical Events Committee \[CEC\] adjudicated) is defined as: * Cardiac death; or * Myocardial infarction (MI) defined as CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave at discharge (periprocedural MI) and using the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI); or * Target vessel revascularization (TVR) de
Conditions Studied
Interventions
- DEVICE Intravascular Lithotripsy
Study Locations (20)
New York
- NYU Langone Health - New York
- Columbia University Medical Center/New York Presbyterian Hospital - New York
- Lenox Hill Hospital - New York
- St. Francis Hospital & Heart Center - Roslyn
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
California
- Scripps Health - La Jolla
- University of California, San Francisco - San Francisco
Georgia
- Piedmont Heart Institute - Atlanta
- Emory University Hospital - Atlanta
Colorado
- South Denver Cardiology Associates, P.C - Littleton
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Florida
- The Cardiac and Vascular Institute - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2025-04-04 |
| Est. Completion | 2027-12 |
| Phase | NA |
What NCT06662500 shows while recruiting
NCT06662500 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, below the 2,997-participant average among 5 other Coronary Arterial Disease (CAD) trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Coronary Arterial Disease (CAD) appearing as the primary indexed condition, and to 1 intervention - of which Intravascular Lithotripsy is the first listed.
NCT06662500 names 20 study sites across 13 states, led by New York, Massachusetts, California.
Frequently Asked Questions
What is clinical trial NCT06662500 about?
NCT06662500 is a clinical study titled "FORWARD CAD IDE Study". The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic d...
What is the current status of trial NCT06662500?
This trial is currently recruiting. It is a NA study. The enrollment target is 408 participants. The study started on 2025-04-04. Estimated completion is 2027-12.
What conditions does trial NCT06662500 study?
This clinical trial studies the following conditions: Coronary Arterial Disease (CAD).
What interventions are being tested in trial NCT06662500?
The interventions under investigation include: Intravascular Lithotripsy (DEVICE).
Who is sponsoring clinical trial NCT06662500?
This trial is sponsored by Shockwave Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06662500 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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