Treatment With Intent to Generate Endovascular Reperfusion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Rapid Medical
- Enrollment
- 160
- Locations
- 17
- Primary Endpoint
- Successful Reperfusion, Defined as mTICI Score ≥ 2b
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
- •Age 18-85 years old (inclusive).
- •Interventionalist estimates that treatment with the Tigertriever (first deployment in target vessel) can be achieved within 8 hours of symptom onset.
- •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.
- •NIH Stroke Scale score of 8-
- •No known significant pre-stroke disability (prestroke mRS 0 or 1).
- •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.
- •For strokes in the anterior circulation, the following imaging criteria should also be met:
- •MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR
- •CT criterion: ASPECTS 6 to 10 on baseline NCCT or CTA-source images,
Exclusion Criteria
- •Subject already participating in another study of an investigational treatment device or treatment.
- •Use of any other intra-arterial recanalization drug or device prior to the Tigertriever (Tigertriever not as first choice device).
- •Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
- •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 \>
- •Glucose \< 50 mg/dl (2.78 mmol/L) or \> 400 mg/dl (22.20 mmol/L).
- •Known hemorrhagic diathesis.
- •Coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 3.
- •Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal.
- •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.
- •Platelet count of less than 50,000/uL.
Outcomes
Primary Outcomes
Successful Reperfusion, Defined as mTICI Score ≥ 2b
Time Frame: Day 0 (end of procedure)
Effectiveness (Successful reperfusion)
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
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.
All-cause Mortality
Time Frame: 90 days post treatment
Safety (All-cause mortality)
Secondary Outcomes
- Modified Rankin Scale (mRS) Score of ≤2(90 days post treatment)