Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
Enrolling by invitation · NCT05453240
Conditions: Intracranial Aneurysms
At a glance
- Research payments reported, 2025
- $447,702
- U.S. investigators named
- 18
- Sites paid
- 17
- Planned or actual enrollment
- 250
About the trial
- Sponsor
- Microvention-Terumo, Inc.
- Dates
- Started 2020-11-17; completion 2026-01-01
- Results posted
- Not yet
The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.
From ClinicalTrials.gov, last updated 2025-06-17. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Microvention, Inc. reported $447,702 in research payments for this study in 2025 (34 payments).
Products named: Stent, Lvis
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
- Guilherme Dabus, MD Neuroradiology · Miami, FL
- Vasu Saini, M.D. Interventional Radiology · Miami Beach, FL
- Ferdinand K. Hui, MD Neurosurgery · Honolulu, HI
- Edgar A. Samaniego Ponton, M.D. Interventional Radiology · Iowa City, IA
- Adel Malek, MD Neurosurgery · Boston, MA
- Aniel Q. Majjhoo, MD Neurology · Flint, MI
- David P. Darrow, MD Neurosurgery · Minneapolis, MN
- Josser E. Delgado, M.D. Neuroradiology · Eden Prairie, MN
- Andrew W. Grande, MD Neurosurgery · Saint Paul, MN
- Alexander Drofa, MD Neurosurgery · Fargo, ND
- Tomoyoshi Shigematsu, M.D., PH.D. Neurosurgery · New York, NY
- Adnan H. Siddiqui, MD, PHD Neurosurgery · Williamsville, NY
- Patrick P. Youssef, M.D. Neurosurgery · Columbus, OH
- Hakeem J. Shakir Neurosurgery · Oklahoma City, OK
- Jonathan R. Lena, M.D. Neurosurgery · Charleston, SC
- Divyajot S. Sandhu, M.D. Neurology · Sioux Falls, SD
- Colin P. Derdeyn, MD Radiology · Charlottesville, VA
- Yince Loh, MD Neurology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Sanford Research $186,880
- University of Iowa Hospital & Clinics, IA $65,250
- The Queens Medical Center, HI $46,130
- University of Virginia Medical Center, VA $32,800
- Abbott Northwestern Hospital, MN $23,000
- Swedish Medical Center, WA $14,800
- Ohio State University $14,634
- Medical University of S Carolina $11,978
- Baptist Health South Florida Inc $11,050
- Tufts Medical Center, MA $10,500
- Hennepin Healthcare Research $7,500
- Mount Sinai Medical Center of Florida, Inc, FL $7,400
- Icahn School of Medicine $6,485
- Research Foundation of Suny $4,899
- Regents of the Univ of Minnesota $2,896
- Board of Regents Univ of Oklahoma $750
- Mclaren Health Care Corporation $750
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.