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)
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ 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.
๐ฐ 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.
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- AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions โ Jonesboro, Arkansas
Explore by condition: All Coronary Arterial Disease (CAD) clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.