🏛️ Verified NIH Record • Updated 2026-08-25

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial) (NCT06321575)

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Nipro Vascular Innovations Americas, Inc

🩺 Plain-English Summary (8th-Grade Level)

The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 20 investigational sites in the U.S.

Who can join: Review the eligibility criteria below.

Location: HonorHealth Scottsdale Osborn Medical Center — Scottsdale, Arizona

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (20 Sites)

  • HonorHealth Scottsdale Osborn Medical Center — Scottsdale, Arizona
  • Pulse Cardiovascular Institute — Scottsdale, Arizona
  • Merced Vascular — Merced, California
  • Palm Vascular Center — Fort Lauderdale, Florida
  • First Coast Cardiovascular Institute — Jacksonville, Florida
  • Radiology and Imaging Specialists of Lakeland — Lakeland, Florida
  • Amavita Research Services — Miami, Florida
  • Cardiovascular Consultants of South Georgia — Thomasville, Georgia
  • Pacific Vascular Institute — ‘Aiea, Hawaii
  • Baton Rouge General Hospital — Baton Rouge, Louisiana
  • Cardiovascular Institute of the South - Houma — Houma, Louisiana
  • Cardiovascular Institute of the South - Lafayette — Lafayette, Louisiana
  • Vascular Breakthroughs — Plymouth, Massachusetts
  • Advanced Heart and Vascular Institute — Flemington, New Jersey
  • Spartanburg Regional Medical Center — Spartanburg, South Carolina
  • Tennessee Center for Clinical Trials — Tullahoma, Tennessee
  • Nextstage Clinical Research - Beaumont — Beaumont, Texas
  • Hope Vascular & Podiatry — Houston, Texas
  • Nextstage Clinical Research - Waco — Waco, Texas
  • Bellin Health — Green Bay, Wisconsin

📞 Contact the Study Coordinator

Phone: (858) 945-0007

Email: Gene.Reu@nipromed.com

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

💰 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 § 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.

💡 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.
🏛️ View Official NIH Record ↗