๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-01

AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease (NCT07512206)

AERO CAD: A Prospective, Multi-Center, Single-Arm Study Evaluating the Shockwave C2 Aero Coronary IVL System in Calcified Coronary Artery Disease

๐ŸŸก Not Yet Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: OPCI Core Laboratories LLC

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

The AERO CAD study is a prospective, multi-center, single-arm, post-market clinical investigation evaluating the procedural performance and clinical outcomes of the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) System in patients with calcified coronary artery disease undergoing percutaneous coronary intervention (PCI). The study will enroll up to 200 subjects across up to 8 U.S. sites. The primary objective is to generate real-world evidence on device performance and clinical outcomes, including target lesion failure at 30 days and procedural success.

Who can join: Review the eligibility criteria below.

Location: Los Robles Regional Medical Center โ€” Thousand Oaks, 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 (8 Sites)

  • Los Robles Regional Medical Center โ€” Thousand Oaks, California
  • Henry Ford St. John Hospital โ€” Detroit, Michigan
  • Jersey Shore University Medical Center โ€” Neptune City, New Jersey
  • The Valley Hospital โ€” Paramus, New Jersey
  • St Francis Hospital & Heart Center โ€” Roslyn, New York
  • Good Samaritan University Hospital โ€” West Islip, New York
  • WellSpan Health, York Hospital โ€” York, Pennsylvania
  • Baylor Scott & White Health - The Heart Hospital Plano โ€” Plano, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (718) 753-4862

Email: fernando.sosa@opci.live

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†—