Trevo Aspiration Proximal Flow Control Registry

Study Overview
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Brief Summary
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This purpose of this retrospective, single-arm, non-randomized, multi-center study is to collect real-world data on the effectiveness of using the TRAP technique in acute ischemic stroke patients undergoing mechanical thrombectomy.

Detailed Description
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The TRAP Registry is designed to collect real-world data on the use of the TRAP technique for mechanical thrombectomy in stroke patients. Recanalization success (as assessed using a TICI Score), along with the time to recanalization and number of passes needed for success will be assessed at the conclusion of the procedure. In addition, neurologic recovery (as evaluated using the Modified Rankin Scale and National Institutes of Health Score) will be assessed at 24 hours, discharge, and 90 days after the thrombectomy procedure.

Official Title
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TRevo Aspiration Proximal Flow Control for Endovascular Stroke Intervention Data Registry

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Device: TRAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA) Subjects in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel Subjects that range in age from 18-85 Subjects with a prestroke modified Rankin scale of 0-1 and presenting with an NIHSS of 8-30 Subjects that the operator feels may be treated with endovascular therapy Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration) Subjects who have consented in accordance with local Institutional Review Board requirements Exclusion Criteria: Absence of large vessel occlusion on neuroimaging Evidence of tandem occlusion on neuroimaging Platelet count < 100 x 10³ cells/mm³ or known platelet dysfunction Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging) Previously documented contrast allergy that is not amenable to medical treatment Women who are pregnant or breastfeeding at time of intervention Evidence of brain hemorrhage on CT and/or MRI at presenting hospital

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated Subjects<br>Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA) and in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel and that meet the other inclusion-exclusion criteria. | Device: TRAP<br>* Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recanalization after Endovascular Intervention | Revascularization as assessed via Thrombolysis in Cerebral Infarction (TICI) score (TICI 2b/3) in affected vessels | Day 0: Conclusion of Thrombectomy Procedure | 
| Time to Recanalization | The time required to attain recanalization (TICI 2b/3) in affected vessels | Day 0: Conclusion of Thrombectomy Procedure | 
| Number of Passes for Recanalization | The total number of passes with the stent retriever need to attain recanalization will be captured. | Day 0: Conclusion of Thrombectomy Procedure | 
| Distal Emboli | Incidence of distal emboli (both to affected vessel and new vessel) will be assessed | Day 0: Conclusion of Thrombectomy Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic Outcomes | Neurologic recovery as assessed by the National Institutes of Health Stroke Scale | 90 days after treatment | 
| Functional Outcomes | Neurologic recovery as assessed by the Modified Rankin Scale | 90 days after treatment | 
| Adverse Events | Incidence of serious procedure-related adverse events will be captured | Day 1, Day 5-7 and Day 90 | 
| TRAP Technique | Success of using all components of the TRAP technique will be assessed by questionnaire for the interventionalist | Day 0: Conclusion of thrombectomy procedure |