Tigertriever Distal Vessels Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Rapid Medical
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Percentage of participants with Symptomatic Intracranial Hemorrhage (SICH) or new infarct within 24 (±12) hours post-procedure.
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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 hours of symptom onset.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Percentage of participants with Symptomatic Intracranial Hemorrhage (SICH) or new infarct within 24 (±12) hours post-procedure.
Time Frame: 24 hours post procedure
Safety Endpoints. SICH shall be defined as Parenchymal Hematoma type 2 coupled with ≥4-point NIHSS deterioration at 24 hours.
Percentage of participants with a new occlusion.
Time Frame: Day 0 (end of procedure)
Safety Endpoints.
Percentage of participants with a TICI Score ≥IIb post procedure after first pass.
Time Frame: Day 0 (end of procedure)
Effectiveness Endpoints
Percentage of participants with a TICI Score ≥IIb post procedure.
Time Frame: Day 0 (end of procedure)
Effectiveness Endpoints