Trials / Active Not Recruiting
Active Not RecruitingNCT04852783
US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
- Status
- Active Not Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Cerus Endovascular, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device.
Detailed description
The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device. This trial is a prospective, multicenter single-arm study. Up to 220 subjects will be enrolled at up to 20 participating investigational sites.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Contour Neurovascular System | Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms. |
Timeline
- Start date
- 2021-08-06
- Primary completion
- 2026-02-20
- Completion
- 2030-02-01
- First posted
- 2021-04-21
- Last updated
- 2026-03-31
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04852783. Inclusion in this directory is not an endorsement.