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NCT01801007 · ClinicalTrials.gov registry record · NA
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
A NA study, sponsored by Microvention-Terumo.
- Completed
- Registry status
- NA
- Development phase
- 145
- Enrollment target
NCT01801007: Completed NA study, sponsored by Microvention-Terumo.
NCT01801007 is a NA study that has completed, run by Microvention-Terumo. The registered enrollment target is 145 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01801007, a NA study, has completed, sponsored by Microvention-Terumo.
- COMPLETED
- Registry status
- NA
- Development phase
- 145 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.
Primary Outcome
The primary effectiveness endpoint has three components: 1) complete occlusion of the target aneurysm assessed by a core laboratory utilizing the Raymond-Roy Scale 2) ≤ 50% stenosis of the parent artery at the target (IA) using the Warfarin-Aspirin Symptomatic Intracranial Disease(WASID) criterion which is defined as greater than 50% luminal loss, 3) alternative treatment of the target IA is defined as re-treatment of the target aneurysm with an alternative treatment modality including open repa
Interventions
- DEVICE Flow Re-Direction Endoluminal Device (FRED)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2013-07 |
| Est. Completion | 2018-01 |
| Phase | NA |
What the finished NCT01801007 record still lists
NCT01801007 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Flow Re-Direction Endoluminal Device (FRED) is the first listed.
NCT01801007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01801007 about?
NCT01801007 is a clinical study titled "Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms". The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.
What is the current status of trial NCT01801007?
This trial is currently completed. It is a NA study. The enrollment target is 145 participants. The study started on 2013-07. Estimated completion is 2018-01.
What interventions are being tested in trial NCT01801007?
The interventions under investigation include: Flow Re-Direction Endoluminal Device (FRED) (DEVICE).
Who is sponsoring clinical trial NCT01801007?
This trial is sponsored by Microvention-Terumo, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01801007's enrollment target sits among peer trials
145 705th of 2000 higher than 1,295 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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