πŸ›οΈ Verified NIH Record β€’ Updated 2024-06-05

Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System (NCT04201132)

Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1 Delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter and a Novel Carotid Stent - the PERFORMANCE II Study

πŸ”΅ Active, Not Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: Contego Medical, Inc.

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

A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA).

Who can join: Review the eligibility criteria below.

Location: Huntsville Hospital β€” Huntsville, Alabama

Age range: 20 Years to 80 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

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

πŸ“ All Participating Trial Locations (38 Sites)

Showing the first 25 of 38 sites.

  • Huntsville Hospital β€” Huntsville, Alabama
  • St. Helena Hospital β€” St. Helena, California
  • MedStar Washington Hospital Center β€” Washington D.C., District of Columbia
  • Manatee Memorial Hospital β€” Bradenton, Florida
  • Lyerly Baptist Neurosurgery β€” Jacksonville, Florida
  • University of Iowa Hospital and Clinics β€” Iowa City, Iowa
  • University of Lexington β€” Lexington, Kentucky
  • Terrebonne General Medical Center β€” Houma, Louisiana
  • White Oak Medical Center β€” Silver Spring, Maryland
  • Dartmouth-Hitchcock Medical Center β€” Lebanon, New Hampshire
  • University at Buffalo Neurosurgery β€” Buffalo, New York
  • Mt. Sinai β€” New York, New York
  • Stony Brook University Medical Center β€” Stony Brook, New York
  • North Carolina Heart and Vascular Research β€” Raleigh, North Carolina
  • Cleveland Clinic Foundation β€” Cleveland, Ohio
  • St. Vincent Hospital β€” Erie, Pennsylvania
  • UPMC Hamot β€” Erie, Pennsylvania
  • Pinnacle Health Cardiovascular Institute β€” Harrisburg, Pennsylvania
  • Lankenau Institute β€” Wynnewood, Pennsylvania
  • Miriam Hospital β€” Providence, Rhode Island
  • Prisma Health Midlands β€” Columbia, South Carolina
  • Prisma Health Upstate β€” Greenville, South Carolina
  • Monument Health - Rapid City Regional Hospital β€” Rapid City, South Dakota
  • North Central Heart Institute β€” Sioux Falls, South Dakota
  • Stern Cardiovascular Foundation β€” Germantown, Tennessee

πŸ’° 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 Β§ 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

πŸ’‘ 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.
πŸ›οΈ View Official NIH Record β†—