Clinical Trial

FORWARD CAD IDE Study

Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 35 amendments
This ClinicalTrials.gov record has been amended 35 times since 2024-10-25; most recent amendment 2026-06-01.
Status change: Active, Not Recruiting → Recruiting 2026-02-03
Status change: Recruiting → Active, Not Recruiting 2025-11-14
Status change: Not Yet Recruiting → Recruiting 2025-03-28
Trial Details
NCT Number NCT06662500
Lead Sponsor Shockwave Medical, Inc.
Conditions Coronary Arterial Disease (CAD)
Enrollment 408 participants
Start Date 2025-04-04
Primary Completion 2025-12-08 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-03