Blood Clot, Ischemic Stroke, Thrombectomy
Conditions
Keywords
thrombus, Clot, Device, Stroke
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMechanical Thrombectomy
You will be asked to provide medical history, take neurological exams in the form of questionnaires, and provide imaging data.
Sponsors
Henry Ford Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as per the approved indication. 2. Tigertriever was used as the first line treatment in the target vessel. 3. A signed informed consent. 4. Age ≥ 18.
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale | From enrollment to 90 days post treatment | Percentage of participants with a modified Rankin Scale (mRS) score ≤2 |
| Primary Effectiveness Endpoint | By the end of the thrombectomy procdure. | Percentage of participants with a mTICI Score ≥IIb |
| Primary Effectiveness Endpoint - mTICI | From time of event to after the first thrombectomy pass. | Percentage of participants with a mTICI Score ≥IIb after the first pass |
Countries
United States
Contacts
CONTACTAlex Chebl, MD
CONTACTKelly Tundo, RN
Outcome results
None listed