๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-30

FORWARD CAD IDE Study (NCT06662500)

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)

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Shockwave Medical, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Scripps Health โ€” La Jolla, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (34 Sites)

Showing the first 25 of 34 sites.

  • Scripps Health โ€” La Jolla, California
  • University of California, San Francisco โ€” San Francisco, California
  • South Denver Cardiology Associates, P.C โ€” Littleton, Colorado
  • Hartford Hospital โ€” Hartford, Connecticut
  • Medstar Washington Hospital Center โ€” Washington D.C., District of Columbia
  • The Cardiac and Vascular Institute โ€” Gainesville, Florida
  • Piedmont Heart Institute โ€” Atlanta, Georgia
  • Emory University Hospital โ€” Atlanta, Georgia
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Brigham and Women's Hospital โ€” Boston, Massachusetts
  • Beth Israel Deaconess Medical Center โ€” Boston, Massachusetts
  • Minneapolis Heart Institute โ€” Minneapolis, Minnesota
  • NYU Langone Health โ€” New York, New York
  • Columbia University Medical Center/New York Presbyterian Hospital โ€” New York, New York
  • Lenox Hill Hospital โ€” New York, New York
  • St. Francis Hospital & Heart Center โ€” Roslyn, New York
  • NC Heart and Vascular Research, LLC โ€” Raleigh, North Carolina
  • The Christ Hospital โ€” Cincinnati, Ohio
  • Providence St. Vincent โ€” Portland, Oregon
  • Wellspan York Hospital โ€” York, Pennsylvania
  • Centennial Heart โ€” Nashville, Tennessee
  • Baylor Scott & White Research Institute Dallas โ€” Dallas, Texas
  • Houston Methodist Hospital โ€” Houston, Texas
  • Baylor Scott and White - The Heart Hospital Baylor Plano โ€” Plano, Texas
  • Intermountain Medical Center Heart Institute โ€” Salt Lake City, Utah

๐Ÿ“ž Contact the Study Coordinator

Phone: (408) 577-7856

Email: RRandoll@its.jnj.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—