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NCT04566263 · ClinicalTrials.gov registry record · NA
Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization
A NA study of Intracranial Aneurysms, sponsored by Methodist Health System.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04566263: Completed NA study of Intracranial Aneurysms, sponsored by Methodist Health System.
NCT04566263 is a NA study of Intracranial Aneurysms that has completed, run by Methodist Health System. The registered enrollment target is 30 participants, below the 43-participant average among 4 other Intracranial Aneurysms trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04566263, a NA study of Intracranial Aneurysms, has completed, sponsored by Methodist Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This device was designed to assist in the stent-assisted coil embolization of intracranial aneurysms, specifically those that have a wide neck that would not otherwise maintain the coil embolization material within the aneurysm because of the wide opening at the base of the aneurysm. This device was designed to treat aneurysms that are: unruptured, wide-necked, intracranial, saccular aneurysms arising from a parent vessel ≥ 2 mm and ≤ 4.5 mm. Wide-necked was defined as having a neck \> 4mm or dome-to-neck ratio \< 2.
Primary Outcome
Successful embolization of intracranial aneurysms defined by angiographic occlusion of greater than or equal to 90%
Conditions Studied
Interventions
- DEVICE Neuroform EZ Stent System
Study Locations (1)
Texas
- Methodist Dallas Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-02-28 |
| Est. Completion | 2021-01-07 |
| Phase | NA |
What the finished NCT04566263 record still lists
NCT04566263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 43-participant average among 4 other Intracranial Aneurysms trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Intracranial Aneurysms appearing as the primary indexed condition, and to 1 intervention - of which Neuroform EZ Stent System is the first listed.
NCT04566263 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04566263 about?
NCT04566263 is a clinical study titled "Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization". This device was designed to assist in the stent-assisted coil embolization of intracranial aneurysms, specifically those that have a wide neck that would not otherwise maintain the coil embolization material within the aneurysm because of the wide opening at the base of the aneurysm. This device was...
What is the current status of trial NCT04566263?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2017-02-28. Estimated completion is 2021-01-07.
What conditions does trial NCT04566263 study?
This clinical trial studies the following conditions: Intracranial Aneurysms.
What interventions are being tested in trial NCT04566263?
The interventions under investigation include: Neuroform EZ Stent System (DEVICE).
Who is sponsoring clinical trial NCT04566263?
This trial is sponsored by Methodist Health System, which has 125 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04566263 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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