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NCT04518670 · ClinicalTrials.gov registry record
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
A clinical trial, sponsored by Rapid Medical.
- Completed
- Registry status
- 90
- Enrollment target
NCT04518670: Completed study, sponsored by Rapid Medical.
NCT04518670 is a clinical trial that has completed, run by Rapid Medical. The registered enrollment target is 90 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04518670 has completed, sponsored by Rapid Medical.
- COMPLETED
- Registry status
- 90 participants
- Enrollment target
Study Summary
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm (IA) defines the neck width as ≥ 4 mm or a dome-to-neck ratio \< 2. The objective of the Postmarket Surveillance Plan is to assess safety and performance as used in postmarket clinical practice in the U.S.
Primary Outcome
Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.
Interventions
- DEVICE Comaneci Embolization Assist Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2024-07-07 |
What the finished NCT04518670 record still lists
NCT04518670 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 90 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Comaneci Embolization Assist Device is the first listed.
NCT04518670 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04518670 about?
NCT04518670 is a clinical study titled "Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)". The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm (IA) defines the neck width as ≥ 4 mm o...
What is the current status of trial NCT04518670?
This trial is currently completed. The enrollment target is 90 participants. The study started on 2020-11-24. Estimated completion is 2024-07-07.
What interventions are being tested in trial NCT04518670?
The interventions under investigation include: Comaneci Embolization Assist Device (DEVICE).
Who is sponsoring clinical trial NCT04518670?
This trial is sponsored by Rapid Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
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