Treatment With Intent to Generate Endovascular Reperfusion
NCT03474549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2024-05-08
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
- DEVICE
-
Tigertriever revascularization device
Mechanical Thrombectomy
Sponsors & Collaborators
-
Rapid Medical
lead INDUSTRY
Principal Investigators
-
Jeffrey L Saver, Dr. · Geffen School of Medicine at UCLA
-
Rishi Gupta, Dr. · WellStar Medical Group
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-09
- Primary Completion
- 2020-04-15
- Completion
- 2020-06-30
- FDA Device
- Yes
Countries
- United States
- Israel
Study Locations
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