Trials / Active Not Recruiting
Active Not RecruitingNCT05409989
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- Sponsor
- Microvention-Terumo, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FRED™ X™ | The FRED™ X™ System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment. |
Timeline
- Start date
- 2022-09-20
- Primary completion
- 2026-04-01
- Completion
- 2030-05-01
- First posted
- 2022-06-08
- Last updated
- 2026-03-24
Locations
23 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05409989. Inclusion in this directory is not an endorsement.