Trials / Completed
CompletedNCT00703794
Researching AXIUM Coiling Experience and Recanalization (RACER)
ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 119 (actual)
- Sponsor
- Medtronic Neurovascular Clinical Affairs · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System. This Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | The AXIUM Progressive Coil System | Embolization of aneurysm |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2012-01-16
- Completion
- 2012-01-16
- First posted
- 2008-06-24
- Last updated
- 2018-10-29
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00703794. Inclusion in this directory is not an endorsement.