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NCT01465841 · ClinicalTrials.gov registry record · NA
Study of the Penumbra Coil 400 System to Treat Aneurysm
A NA study, sponsored by Penumbra.
- Completed
- Registry status
- NA
- Development phase
- 517
- Enrollment target
NCT01465841: Completed NA study, sponsored by Penumbra.
NCT01465841 is a NA study that has completed, run by Penumbra. The registered enrollment target is 517 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01465841, a NA study, has completed, sponsored by Penumbra.
- COMPLETED
- Registry status
- NA
- Development phase
- 517 participants
- Enrollment target
Study Summary
This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.
Primary Outcome
The data will be captured at the end of the coiling procedure which is standard for aneurysm studies.
Interventions
- DEVICE PC 400 coils (Penumbra )
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 517 participants |
| Start Date | 2011-11 |
| Est. Completion | 2017-06 |
| Phase | NA |
What the finished NCT01465841 record still lists
NCT01465841 is an interventional study that assigns participants to a tested intervention. The registered 517 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 (63% lower).
The record links to 0 conditions, and to 1 intervention - of which PC 400 coils (Penumbra ) is the first listed.
NCT01465841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01465841 about?
NCT01465841 is a clinical study titled "Study of the Penumbra Coil 400 System to Treat Aneurysm". This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approxim...
What is the current status of trial NCT01465841?
This trial is currently completed. It is a NA study. The enrollment target is 517 participants. The study started on 2011-11. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01465841?
The interventions under investigation include: PC 400 coils (Penumbra ) (DEVICE).
Who is sponsoring clinical trial NCT01465841?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01465841's enrollment target sits among peer trials
517 191st of 2000 higher than 1,810 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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