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The purpose of this research study is to collect data about the effectiveness (i.e. how the device works) and safety (how safe it is to use such a device) of the Tigertriever in restoring blood flow by removing thrombus (or blood clot) from a large intracranial vessel (blood vessel in the brain) in patients experiencing ischemic stroke within 8 hours of symptom onset.
You have been asked to take part in a research study because you have recently been admitted for large vessel occlusion (LVO) and are being treated by Tigertriever.
The treatment is a standard of care (SOC), and if you agree to take part in this study, your participation will include an additional study visit after 3 months. Your study visit will take place at Henry Ford Hospital Neurology or respective collaborator.
For some research studies, such as the one you are being asked to join, it is important that you do not learn the results of certain tests. Whether you intend it or not, sometimes learning this information may make you change your actions and behaviors in ways that could impact the outcome of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrombectomy Treated Patients | Patients are enrolled only if the use of the Tigertreiver is used during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Thrombectomy | Procedure | You will be asked to provide medical history, take neurological exams in the form of questionnaires, and provide imaging data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale | Percentage of participants with a modified Rankin Scale (mRS) score ≤2 | From enrollment to 90 days post treatment |
| Primary Effectiveness Endpoint | Percentage of participants with a mTICI Score ≥IIb | By the end of the thrombectomy procdure. |
| Primary Effectiveness Endpoint - mTICI | Percentage of participants with a mTICI Score ≥IIb after the first pass | From time of event to after the first thrombectomy pass. |
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Inclusion Criteria:
Exclusion Criteria:
-1. Evidence of acute brain hemorrhage on NCCT or MR at admission. 2. Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months.
3. pre-stroke disability (pre-stroke mRS ≥ 2).
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The registry will include male or female subjects age > 18 who present with LVO and are treated with the Tigertriever as per the approved indication.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Chebl, MD | Contact | 313-916-2644 | achebl1@hfhs.org | |
| Kelly Tundo, RN | Contact | 313-916-1102 | kciach1@hfhs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
De-identified data will only be shared and used for publication.
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |