🏛️ Verified NIH Record • Updated 2025-04-01

Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting (NCT04900844)

A Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGuard™ Carotid Stent System When Used to Treat Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing Carotid Artery Stenting

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: InspireMD

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

The objective of this pivotal study is to evaluate the safety and efficacy of the CGuard™ Carotid Stent System in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS) to a performance goal developed from published CAS literature.

Who can join: Review the eligibility criteria below.

Location: University of Florida — Jacksonville, Florida

Age range: 19 Years to 80 Years

🧪 Interventions in This Study

📋 "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 (18 Sites)

  • University of Florida — Jacksonville, Florida
  • Oschner Health — New Orleans, Louisiana
  • Ascension, St. John Hospital — Detroit, Michigan
  • Mercy Hospital — St Louis, Missouri
  • University of Buffalo — Buffalo, New York
  • Columbia University Irving Medical Center — New York, New York
  • Stony Brook University Hospital — Stony Brook, New York
  • Novant Health — Winston-Salem, North Carolina
  • Cleveland Clinic — Cleveland, Ohio
  • UPMC-Pinnacle — Harrisburg, Pennsylvania
  • Miriam Hospital — Providence, Rhode Island
  • Prisma Health-Upstate — Greenville, South Carolina
  • Avera Heart Hospital — Sioux Falls, South Dakota
  • Ballad CVA Heart Institute — Kingsport, Tennessee
  • Turkey Creek Medical Center — Knoxville, Tennessee
  • Ascension Seton, Seton Heart Institute — Austin, Texas
  • Leszek Leic Upper-Silesian Medical Centre of the Silesian Medical University — Katowice,
  • John Paul II Hospital — Krakow,

💰 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.

More studies in Carotid Artery Stenosis

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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 ↗