ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Neuravi Inc.
- Enrollment
- 228
- Locations
- 12
- Primary Endpoint
- Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
- •Aged between 18 years and 85 years (inclusive).
- •A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- •NIHSS score ≥8 and ≤
- •Pre-ictal mRS score of 0 or
- •The interventionalist estimates that at least one deployment of the EmboTrap device can be completed within 8 hours from the onset of symptoms.
- •Patients for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA.
- •IV-tPA, if used, was initiated within 3 hrs of stroke onset (onset time is defined as the last time when the patient was witnessed to be at baseline), with investigator verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight.
- •Angiographic confirmation of an occlusion of an ICA (including T or L occlusions), M1 or M2 MCA, VA, or BA with mTICI flow of 0 -
- •For strokes in the anterior circulation the following imaging criteria should also be met:
Exclusion Criteria
- •Life expectancy likely less than 6 months.
- •Females who are pregnant or breastfeeding.
- •History of severe allergy to contrast medium.
- •Known nickel allergy at time of treatment.
- •Known current use of cocaine at time of treatment.
- •Patient has suffered a stroke in the past 3 months.
- •The patient presents with an NIHSS score \<8 or \>25 or is physician assessed as being in a clinically relevant uninterrupted coma.
- •Subject participating in another study involving an investigational device or drug.
- •Use of warfarin anticoagulation or any Novel Anticoagulant with International Normalized Ratio (INR) \>3.
- •Platelet count \<50,000/μL.
Outcomes
Primary Outcomes
Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)
Time Frame: Post-treatment
Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap device. Patients treated with rescue prior to completion of three passes with EmboTrap were treated as failures to meet the primary revascularization endpoint. (Post measurement of the primary endpoint some patients subsequently received additional treatment.) - mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of \<50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)
Time Frame: 24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure
The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH). sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention. SADE was categorized as any serious adverse event that was deemed to be caused by the study device.
Secondary Outcomes
- Procedure Time(Post-treatment)
- Occurrence of Procedure Related Serious Adverse Events (PRSAE)(90(±14) days Post Procedure)
- All Procedure-related Mortality(Day 7 post-procedure)
- All-cause Mortality(90(±14) days Post Procedure)
- Occurrence of Symptomatic Intracerebral Hemorrhage (sICH)(24(-8/+12) hours post-procedure)
- Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory(24(-8/+12) hours post-procedure)
- Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2(90(±14) days Post Procedure)
- Occurrence of Serious Adverse Device Effects (SADE)(90(±14) days Post Procedure)
- Occurrence of Neurological Deterioration(24(-8/+12) hours post-procedure)
- Time to Treat(Post-treatment)