FRED™ Flow Diverter
US Pivotal Trial: Pivotal Study of the FRED™ Stent System in the Treatment of Intracranial Aneurysms
"As compared with historically derived performance benchmarks, the FRED™ flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms."
- Patients
145
- Countries
US & Japan
- Clinical Centers
23
- Design
Single arm prospective
- Scope
Patients 22-75 y.o. with a single non acutely ruptured target aneurysm located in the ICA.
- Purpose
Evaluate safety and effectiveness of the FRED™ in support of an application for Food and Drug Administration approval in the USA.
Endpoints
Effectiveness: Complete Occlusion with stenosis ≤50% and no retreatment within 12 months (assessed by Corelab)
Safety: Death or major stroke (≥ 4 points increase in the National Institute of Health Stroke Scale score) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year.
Efficacy results
At 12 months:
Effectiveness endpoint result: 57.6%
Complete occlusion: 62.9%
Retreatment rate: 5.7%
Safety results
At 12 months:
Safety endpoint event rate: 6.2% (incl. 2.8% with rate of neurological death and mRS >2)
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT01801007
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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