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NCT04057352 · ClinicalTrials.gov registry record · NA
Citadel Embolization Device Study
A NA study of Unruptured Wide-neck Aneurysms, sponsored by Stryker Neurovascular.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT04057352: Active NA study of Unruptured Wide-neck Aneurysms, sponsored by Stryker Neurovascular.
NCT04057352 is a NA study of Unruptured Wide-neck Aneurysms that is active but no longer recruiting, run by Stryker Neurovascular. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04057352, a NA study of Unruptured Wide-neck Aneurysms, is active but no longer recruiting, sponsored by Stryker Neurovascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms.
Primary Outcome
Occurring within 12 months post-procedure as adjudicated by an independent Clinical Events Committee (CEC) * With major ipsilateral stroke defined as a stroke associated with an increase in NIHSS score ≥ 4 points persisting ≥ 24 hours, and; * With disabling stroke defined as a stroke that results in a modified Rankin Scale (mRS) score ≥ 3 assessed at a minimum of 90 days post-stroke event.
Conditions Studied
Interventions
- DEVICE Citadel Embolization Device
Study Locations (20)
California
- Cedars-Sinai Medical Center - Los Angeles
- California Pacific Medical Center - San Francisco
- UCSF Medical Center - San Francisco
- John Muir Health - Walnut Creek
Florida
- University of Florida - Gainesville
- Baptist Health - Jacksonville
- University of Miami/Jackson Memorial - Miami
- Tampa General Hospital - Tampa
Kentucky
- Baptist Health - Lexington
- University of Kentucky - Lexington
Michigan
- McLaren Health Center - Flint
- Spectrum Health - Grand Rapids
Arizona
- Carondelet St. Joseph Hospital - Tucson
Colorado
- RIA Neurovascular - Englewood
Illinois
- Northwestern University - Chicago
Indiana
- Indiana Methodist - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2026-11-15 |
| Phase | NA |
What the registry record for NCT04057352 still lists
NCT04057352 is an interventional study that assigns participants to a tested intervention. The registered 150 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 (89% lower).
The record links to 1 condition, with Unruptured Wide-neck Aneurysms appearing as the primary indexed condition, and to 1 intervention - of which Citadel Embolization Device is the first listed.
NCT04057352 names 20 study sites across 12 states, led by California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04057352 about?
NCT04057352 is a clinical study titled "Citadel Embolization Device Study". The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms.
What is the current status of trial NCT04057352?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2019-07-18. Estimated completion is 2026-11-15.
What conditions does trial NCT04057352 study?
This clinical trial studies the following conditions: Unruptured Wide-neck Aneurysms.
What interventions are being tested in trial NCT04057352?
The interventions under investigation include: Citadel Embolization Device (DEVICE).
Who is sponsoring clinical trial NCT04057352?
This trial is sponsored by Stryker Neurovascular, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04057352 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04057352's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 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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