RecruitingNot ApplicableNCT06662500

FORWARD CAD IDE Study

Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System With the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)

Sponsor

Shockwave Medical, Inc.

Enrollment

408 participants

Start Date

Apr 4, 2025

Study Type

INTERVENTIONAL

Conditions

Coronary Arterial Disease (CAD)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Intravascular Lithotripsy for people with coronary arterial disease (cad). The study is currently recruiting participants at 34 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntravascular 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.

Locations(34)

Scripps Health

La Jolla, California, United States

University of California, San Francisco

San Francisco, California, United States

South Denver Cardiology Associates, P.C

Littleton, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

The Cardiac and Vascular Institute

Gainesville, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

NYU Langone Health

New York, New York, United States

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

St. Francis Hospital & Heart Center

Roslyn, New York, United States

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

Providence St. Vincent

Portland, Oregon, United States

Wellspan York Hospital

York, Pennsylvania, United States

Centennial Heart

Nashville, Tennessee, United States

Baylor Scott & White Research Institute Dallas

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Baylor Scott and White - The Heart Hospital Baylor Plano

Plano, Texas, United States

Intermountain Medical Center Heart Institute

Salt Lake City, Utah, United States

Overlake Medical Center

Bellevue, Washington, United States

Swedish Medical

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

Basildon University Hospital

Basildon, UK, United Kingdom

Bristol Heart Institute

Bristol, UK, United Kingdom

Leeds Teaching Hospital NHS Trust

Leeds, UK, United Kingdom

Glenfield Hospital

Leicester, UK, United Kingdom

St. Thomas Hospital

London, UK, United Kingdom

St. George's Hospital

London, UK, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06662500

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