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FORWARD CAD IDE Study

NCT06662500 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2026-05-04

No results posted yet for this 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.

Conditions

  • Coronary Arterial Disease (CAD)

Interventions

DEVICE

Intravascular Lithotripsy

The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary Catheter is intended to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to balloon crossing, full dilatation or subsequent uniform coronary stent expansion.

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert W Yeh, M.D., M.Sc, M.B.A · Beth Israel Deaconess Medical Center

  • James C Spratt, MD, MB, ChB, FRCP, FESC, FACC · St. George's University NHS Trust

  • Robert F Riley, MD, MS, FACC, FAHA, FSCAI · Overlake Medical Center & Clinics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-04
Primary Completion
2025-12-08
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06662500 on ClinicalTrials.gov