Trials / Completed
CompletedNCT03474549
Treatment With Intent to Generate Endovascular Reperfusion
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Rapid Medical · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Tigertriever is a CE marked mechanical revascularization device indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. The objective of the TIGER Study is to evaluate the safety and effectiveness of the Tigertriever device in restoring blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke due to a large vessel occlusion (LVO). This study is designed to support substantial equivalence to approved and marketed products such as the Solitaire or Trevo Retriever.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tigertriever revascularization device | Mechanical Thrombectomy |
Timeline
- Start date
- 2018-05-09
- Primary completion
- 2020-04-15
- Completion
- 2020-06-30
- First posted
- 2018-03-22
- Last updated
- 2024-05-08
- Results posted
- 2024-05-08
Locations
17 sites across 2 countries: United States, Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03474549. Inclusion in this directory is not an endorsement.