Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT05531461
Eligibility Criteria:
Inclusion Criteria:
1. Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as indicated per the approved IFU.
2. Tigertriever was used as the first line treatment in the target vessel.
3. A signed informed consent.
4. Age 18-75 years (inclusive).
5. No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
Exclusion Criteria:
1. Use of any other IA recanalization device prior to the Tigertriever in the target vessel, including aspiration catheter.
2. Evidence of acute brain hemorrhage on CT and/or MRI at admission.
3. Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months.
4. Probable cerebral amyloid angiopathy.
5. Pre-stroke diagnosed dementia and/or prescribed cholinesterase inhibitors.
6. Pre-stroke diagnosed and/or currently treated major depression.
7. Pre-stroke learning or intellectual disability.
8. Anticipated inability to obtain 6-month follow-up assessments.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05531461
Study Brief:
Protocol Section:
NCT05531461