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NCT04106583 · ClinicalTrials.gov registry record
Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
A clinical trial, sponsored by Penumbra.
- Completed
- Registry status
- 572
- Enrollment target
NCT04106583: Completed study, sponsored by Penumbra.
NCT04106583 is a clinical trial that has completed, run by Penumbra. The registered enrollment target is 572 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04106583 has completed, sponsored by Penumbra.
- COMPLETED
- Registry status
- 572 participants
- Enrollment target
Study Summary
The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.
Primary Outcome
Adequate occlusion defined as Raymond-Roy Class I and II at final follow-up Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Interventions
- DEVICE WAVE, as part of the SMART COIL System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 572 participants |
| Start Date | 2019-11-05 |
| Est. Completion | 2023-08-02 |
What the finished NCT04106583 record still lists
NCT04106583 is an observational study that tracks outcomes without assigning an intervention. The registered 572 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which WAVE, as part of the SMART COIL System is the first listed.
NCT04106583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04106583 about?
NCT04106583 is a clinical study titled "Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities". The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusio...
What is the current status of trial NCT04106583?
This trial is currently completed. The enrollment target is 572 participants. The study started on 2019-11-05. Estimated completion is 2023-08-02.
What interventions are being tested in trial NCT04106583?
The interventions under investigation include: WAVE, as part of the SMART COIL System (DEVICE).
Who is sponsoring clinical trial NCT04106583?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
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