Michigan Initial Experience Using Tigertriever for Thrombectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mechanical Thrombectomy.
- Who it may be relevant to
- Registry conditions: Blood Clot, Thrombectomy, Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Procedure Mechanical Thrombectomy
You will be asked to provide medical history, take neurological exams in the form of questionnaires, and provide imaging data.
Primary outcome measures
- Modified Rankin Scale [Time frame: From enrollment to 90 days post treatment]
- Primary Effectiveness Endpoint [Time frame: By the end of the thrombectomy procdure.]
- Primary Effectiveness Endpoint - mTICI [Time frame: From time of event to after the first thrombectomy pass.]
Eligibility criteria
Inclusion criteria
- Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as per the approved indication.
- Tigertriever was used as the first line treatment in the target vessel.
- A signed informed consent.
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Henry Ford Hospital — Detroit
Identifiers
NCT: NCT07363525 · 18750