Trials / Completed
CompletedNCT01054560
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 144 (actual)
- Sponsor
- Medtronic Neurovascular Clinical Affairs · Industry
- Sex
- All
- Age
- 22 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SOLITAIRE™ Device | The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure |
| DEVICE | MERCI® Device | The MERCI® Device is the control device that will be used in the interventional procedure. |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2010-01-22
- Last updated
- 2016-10-26
- Results posted
- 2016-10-26
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01054560. Inclusion in this directory is not an endorsement.