- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07363525
Michigan Initial Experience Using Tigertriever for Thrombectomy (MIGHTY)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kelly Tundo, RN
- Phone Number: 313-916-1102
- Email: kciach1@hfhs.org
Study Contact Backup
- Name: Alex Chebl, MD
- Phone Number: 313-916-2644
- Email: achebl1@hfhs.org
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Hospital
-
Contact:
- Kelly Tundo
- Email: kciach1@hfhs.org
-
Contact:
- Alex B Chebl, MD
- Phone Number: 3132070432
- Email: achebl1@hfhs.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Thrombectomy Treated Patients
Patients are enrolled only if the use of the Tigertreiver is used during surgery.
|
You will be asked to provide medical history, take neurological exams in the form of questionnaires, and provide imaging data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Rankin Scale
Time Frame: From enrollment to 90 days post treatment
|
Percentage of participants with a modified Rankin Scale (mRS) score ≤2
|
From enrollment to 90 days post treatment
|
|
Primary Effectiveness Endpoint
Time Frame: By the end of the thrombectomy procdure.
|
Percentage of participants with a mTICI Score ≥IIb
|
By the end of the thrombectomy procdure.
|
|
Primary Effectiveness Endpoint - mTICI
Time Frame: From time of event to after the first thrombectomy pass.
|
Percentage of participants with a mTICI Score ≥IIb after the first pass
|
From time of event to after the first thrombectomy pass.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18750
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.