Ischemic Stroke
Conditions
Keywords
Mechanical thrombectomy,, Brain, Brain clot, Brain infarction, Cerebral ischemia, Neurovascular intervention, Revascularization, Reperfusion, Stent retriever, Tigertriever, Stroke, Rapid Medical
Brief summary
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. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. The objective of the TIGER Study is to evaluate the safety and effectiveness of the Tigertriever device in restoring blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke due to a large vessel occlusion (LVO). This study is designed to support substantial equivalence to approved and marketed products such as the Solitaire or Trevo Retriever.
Interventions
DEVICETigertriever revascularization device
Mechanical Thrombectomy
Sponsors
Rapid Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. New focal neurologic deficit consistent with being of acute cerebral ischemia origin. 2. Age 18-85 years old (inclusive). 3. Interventionalist estimates that treatment with the Tigertriever (first deployment in target vessel) can be achieved within 8 hours of symptom onset. 4. Patient either: a) eligible for, and received, IV t-PA within 3 hours of symptom onset, at the correct 0.9 mg/kg dose, or b) ineligible for IV t-PA. 5. NIH Stroke Scale score of 8-29. 6. No known significant pre-stroke disability (prestroke mRS 0 or 1). 7. Catheter angiographic confirmation of a large vessel occlusion in the intracranial internal carotid artery, the M1 or M2 segments of the middle cerebral artery, the intracranial vertebral artery, or the basilar artery that is accessible to Tigertriever device. 8. For strokes in the anterior circulation, the following imaging criteria should also be met: 1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR 2. CT criterion: ASPECTS 6 to 10 on baseline NCCT or CTA-source images, 9. For strokes in the posterior circulation, the following imaging criterion should also be met: pcASPECTS score 8 to 10 on baseline NCCT, CTA-source images, or DWI MRI. 10. Anticipated life expectancy of at least 6 months. 11. A signed informed consent by patient or a Legally Authorized Representative or independent physician in case of oral consent.
Exclusion criteria
1. Subject already participating in another study of an investigational treatment device or treatment. 2. Use of any other intra-arterial recanalization drug or device prior to the Tigertriever (Tigertriever not as first choice device). 3. Angiographically evident excessive arterial tortuosity precluding device access to the thrombus. 4. For all patients, severe sustained hypertension with SBP \>220 and/or DBP \>120; for patients treated with IV tPA, sustained hypertension despite treatment with SBP \>185 and/or DBP \> 110. 5. Glucose \< 50 mg/dl (2.78 mmol/L) or \> 400 mg/dl (22.20 mmol/L). 6. Known hemorrhagic diathesis. 7. Coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 3.0. 8. Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal. 9. Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible. 10. Platelet count of less than 50,000/uL. 11. History of severe allergy to contrast medium, nickel, or Nitinol. 12. Intracranial hemorrhage. 13. Significant mass effect with midline shift. 14. Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter). 15. Stenosis or any occlusion in the deployment site or in a proximal vessel requiring treatment or preventing device access to the thrombus (for example, stenosis or occlusion in the cervical internal carotid artery). 16. Females who are pregnant or breastfeeding. 17. Known current use of cocaine at time of treatment. 18. Prior recent stroke in the past 3 months. 19. Renal failure with serum creatinine \>3.0 or Glomerular Filtration Rate (GFR) \<30. 20. Known cerebral vasculitis. 21. Rapidly improving neurological status defined as improvement of greater than 8 points on the NIHSS or improvement to NIHSS of \< 6 prior to procedure 22. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories. 23. Ongoing seizure due to stroke. 24. Evidence of active systemic infection. 25. Known cancer with metastases. 26. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis. 27. Evidence of dissection in the extra or intracranial cerebral arteries. 28. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation). 29. Aneurysm in target vessel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Reperfusion, Defined as mTICI Score ≥ 2b | Day 0 (end of procedure) | Effectiveness (Successful reperfusion) |
| All-cause Mortality | 90 days post treatment | Safety (All-cause mortality) |
| Symptomatic Intracranial Hemorrhage (sICH) Defined as Any Parenchymal Hematoma Type 2, Remote Intracerebral Hemorrhage, Subarachnoid Hemorrhage, or Intraventricular Hemorrhage That is the Predominant Cause of ≥4 Point NIHSS Deterioration at 24 Hours | 24 hours post procedure | Safety (Symptomatic intracranial hemorrhage (sICH)) defined as any parenchymal hematoma type 2, remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage that is the predominant cause of ≥4 point NIHSS deterioration at 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) Score of ≤2 | 90 days post treatment | modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tigertriever Revascularization Device Mechanical thrombectomy with Tigertriever
Tigertriever revascularization device: Mechanical Thrombectomy | 160 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 31 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Tigertriever Revascularization Device |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 13.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 134 Participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 31 / 160 |
| other Total, other adverse events | 120 / 160 |
| serious Total, serious adverse events | 71 / 160 |
Outcome results
Primary
All-cause Mortality
Safety (All-cause mortality)
Time frame: 90 days post treatment
Population: main study cohort (post lead-in)- 117 all patients (including lead-in)- 160
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tigertriever Revascularization Device | All-cause Mortality | 31 Participants |
Primary
Successful Reperfusion, Defined as mTICI Score ≥ 2b
Effectiveness (Successful reperfusion)
Time frame: Day 0 (end of procedure)
Population: main study cohort (post lead-in)- 117 overall patients (including lead-in)- 160
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tigertriever Revascularization Device | Successful Reperfusion, Defined as mTICI Score ≥ 2b | 130 Participants |
Primary
Symptomatic Intracranial Hemorrhage (sICH) Defined as Any Parenchymal Hematoma Type 2, Remote Intracerebral Hemorrhage, Subarachnoid Hemorrhage, or Intraventricular Hemorrhage That is the Predominant Cause of ≥4 Point NIHSS Deterioration at 24 Hours
Safety (Symptomatic intracranial hemorrhage (sICH)) defined as any parenchymal hematoma type 2, remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage that is the predominant cause of ≥4 point NIHSS deterioration at 24 hours.
Time frame: 24 hours post procedure
Population: main study cohort (post lead-in)- 117 overall patients (including lead-in)- 160
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tigertriever Revascularization Device | Symptomatic Intracranial Hemorrhage (sICH) Defined as Any Parenchymal Hematoma Type 2, Remote Intracerebral Hemorrhage, Subarachnoid Hemorrhage, or Intraventricular Hemorrhage That is the Predominant Cause of ≥4 Point NIHSS Deterioration at 24 Hours | 3 Participants |
Secondary
Modified Rankin Scale (mRS) Score of ≤2
modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
Time frame: 90 days post treatment
Population: Sample sizes vary due to missing data at 90 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tigertriever Revascularization Device | Modified Rankin Scale (mRS) Score of ≤2 | 86 Participants |