🏛️ Verified NIH Record • Updated 2026-03-23
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study (NCT05409989)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Microvention-Terumo, Inc.
🩺 Plain-English Summary (8th-Grade Level)
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.
Who can join: Review the eligibility criteria below.
Location: Memorial Healthcare Systems — Hollywood, Florida
Age range: 22 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- Memorial Healthcare Systems — Hollywood, Florida
- Orlando Health — Orlando, Florida
- Queen's Medical Center — Honolulu, Hawaii
- University of Iowa — Iowa City, Iowa
- University of Kansas — Kansas City, Kansas
- Baptist Healthcare System — Louisville, Kentucky
- Norton Healthcare — Louisville, Kentucky
- Ochsner Health — New Orleans, Louisiana
- The Johns Hopkins University — Baltimore, Maryland
- Massachusetts General Brigham Incorporated — Boston, Massachusetts
- UMass Memorial Health — Worcester, Massachusetts
- Albany Medical Center — Albany, New York
- University at Buffalo — Buffalo, New York
- Northwell Health — Manhasset, New York
- Mount Sinai — New York, New York
- Stony Brook University — Stony Brook, New York
- Montefiore Medical Center — The Bronx, New York
- Ohio State University — Columbus, Ohio
- ProMedica Toledo Hospital — Toledo, Ohio
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
- University of Pennsylvania — Philadelphia, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania
- Houston Methodist Hospital — Houston, Texas
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.