MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Active, not recruiting · Not applicable · NCT05409989
Conditions: Intracranial Aneurysm
At a glance
- Research payments reported, 2025
- $644,547
- U.S. investigators named
- 25
- Sites paid
- 23
- Planned or actual enrollment
- 154
About the trial
- Sponsor
- Microvention-Terumo, Inc.
- Tested
- FRED™ X™ (device)
- Dates
- Started 2022-09-20; completion 2030-05
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-03-24. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Microvention, Inc. reported $644,547 in research payments for this study in 2025 (170 payments).
Products named: Stent, Web Aneurysm Embolization System, Sofia 6f-131cm Str, Hydrosoft Advanced, Hypersoft Advanced
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Brijesh P. Mehta, MD Neuroradiology · Hollywood, FL
- Jay A. Vachhani, M.D. Neurosurgery · Orlando, FL
- Ferdinand K. Hui, MD Neurosurgery · Honolulu, HI
- Yi J. Zhang, MD Neurosurgery · Honolulu, HI
- Edgar A. Samaniego Ponton, M.D. Interventional Radiology · Iowa City, IA
- Koji C. Ebersole, M.D. Neurosurgery · Kansas City, KS
- Tom L. Yao, MD Neurosurgery · Louisville, KY
- Gabriel A. Vidal, M.D. Neurology · New Orleans, LA
- Jasmeet Singh, MD Neuroradiology · Worcester, MA
- Justin M. Caplan, M.D. Neurosurgery · Baltimore, MD
- Daniel Walzman, M.D. Interventional Radiology · Hackensack, NJ
- David J. Altschul, M.D. Student in an Organized Health Care Education/Training Program · Bronx, NY
- David J. Fiorella, M.D., PH.D. Neuroradiology · Stony Brook, NY
- Alexandra R. Paul, M.D. Student in an Organized Health Care Education/Training Program · Albany, NY
- Tomoyoshi Shigematsu, M.D., PH.D. Neurosurgery · New York, NY
- Adnan H. Siddiqui, MD, PHD Neurosurgery · Williamsville, NY
- Henry H. Woo, MD Neurosurgery · Stony Brook, NY
- Patrick P. Youssef, M.D. Neurosurgery · Columbus, OH
- Syed F. Zaidi, M.D. Neurology · Toledo, OH
- Hakeem J. Shakir Neurosurgery · Oklahoma City, OK
- Jan-karl Burkhardt, M.D. Neurosurgery · Philadelphia, PA
- Clemens M. Schirmer, MD Neurosurgery · Danville, PA
- Stavropoula I. Tjoumakaris, MD Neurosurgery · Philadelphia, PA
- Orlando M. Diaz, M.D. Interventional Radiology · Houston, TX
- Haris Kamal, M.D. Neurology · Houston, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Thomas Jefferson University $114,704
- Orlando Health, FL $54,246
- Memorial Regional Hospital, FL $51,621
- Research Foundation of Suny $48,753
- Ochsner Medical Center Acute, LA $39,187
- Johns Hopkins University $35,893
- Hospital of Univ of Pennsylvania, PA $34,263
- Ohio State University $32,601
- The Queens Medical Center, HI $29,920
- Icahn School of Medicine $28,768
- University of Massachusetts $25,854
- Biomedical Research Alliance $25,432
- Albany Medical College $21,836
- Houston Methodist Hospital, TX $18,652
- Hackensack Meridian Health Found $17,750
- University of Iowa Hospital & Clinics, IA $17,714
- Promedica Toledo Hospital, OH $17,566
- Board of Regents Univ of Oklahoma $9,469
- Norton Healthcare Inc $6,725
- University of Kansas Medical $6,468
- Geisinger Clinic $3,840
- The Feinstein Institutes $2,312
- University of Buffalo Neurosurgery $975
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.