Status:
TERMINATED
Tigertriever Distal Vessels Registry
Lead Sponsor:
Rapid Medical
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Brief Summary
A registry study to collect data on the Tigertriever device at restoring blood flow by removing clots in M2 or distal vessels in patients experiencing acute ischemic stroke, during commercial use.
Detailed Description
Tigertriever is a CE marked mechanical revascularization device indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 ...
Eligibility Criteria
Inclusion
- Patients who present with acute ischemic stroke, who can be treated within 6 hours of symptoms onset, who are either refractory to or ineligible for IV t-PA treatment and intend to be treated with thrombectomy.
- Patients ≥18
- NIHSS Score of ≥2
- Angiographically confirmed occlusion in a M2 or distal (medium to small) branch that is accessible to the Tigertriever device (17 or 13) as determined by the vessel diameter (≥1mm).
- Anticipated life expectancy of at least 6 months from presentation
- Signed informed consent form by the patient or a legally acceptable representative.
Exclusion
- Extended infarct - ischemic changes \>1/3 MCA territory / 100 ml tissue or ASPECT score \<5
- Pre- stroke mRS ≥ 2
- Unknown time of stroke symptom onset
- Vessel diameter \< 1mm
- Angiographically evident extreme vessel tortuosity that may preclude the device from reaching the target area.
- Occlusion/stenosis proximal to thrombus that precludes safe retrieval
- Medical co-morbidities including but not limited to:
- Uncontrolled coagulopathy such as International Normalized Ratio (INR) of \> 3.0 or platelets count \< 40 x109/L or APTT \>50 sec
- Serious concurrent medical illness: myocardial infarction, seizures, sepsis, uncontrolled diabetes, uncontrolled hypertension, brain tumor, renal impairment (eGFR \<60).
- Baseline glucose \< 2.7 or \> 22.2 mmol/L
- Imaging features of:
- raised intracranial pressure or significant mass effect (for example, midline shift, severe sulcal effacement, transcompartmental herniation)
- intracranial hemorrhage
- vascular malformation or aneurysm
- significant vascular abnormality such as carotid dissection, complete carotid occlusion or large/medium vessel vasculitis
- Allergy/sensitivity to nickel-titanium or contrast media
- Females who are pregnant or lactating
- Unable to obtain informed consent from the patient or a suitable legal representative
- Any other contraindication to thrombectomy
Key Trial Info
Start Date :
February 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03871309
Start Date
February 7 2020
End Date
October 10 2023
Last Update
April 12 2024
Active Locations (1)
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1
Imperial College Healthcare
London, United Kingdom