The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.
The study is a prospective, randomized, multi-center, Phase II/III (feasibility/pivotal), adaptive, controlled trial, designed to demonstrate that mechanical thrombectomy using the Trevo Retriever with medical management is superior to medical management alone in improving clinical outcomes at 90 days in appropriately selected wake up and late presenting acute ischemic stroke subjects.
The intent of this study is to support the use of the Trevo Retriever beyond the currently labeled 8 hour indicated time limit in wake up, unclear onset, and late presenting ischemic stroke subjects, who currently have no other option besides medical management of their symptoms.
Patients with wake-up strokes, strokes with unclear onset time, and witnessed late presenting strokes may potentially benefit from intra-arterial reperfusion therapy. However, an important indicator of whether subjects will benefit or not during this later time window is the confirmation of a large vessel occlusion (LVO), and assessment of the core infarct volume relative to the volume of salvageable penumbra. Therefore, standardized imaging selection of subjects is required for inclusion into the study.
This trial has been designed with subject safety in mind, as a seamless Phase II (feasibility) / Phase III (pivotal) adaptive design, in order to address the concerns around potential unknown harms to enrolled subjects. This study will help to answer the question of whether carefully selecting subjects by using Clinical Imaging Mismatch will allow acute ischemic stroke patients who present at or beyond 6 hours from Time Last Seen Well (TLSW) to be considered for intra-arterial intervention. If Trevo thrombectomy plus medical management leads to better clinical outcomes over medical management alone, more patients in the future could receive endovascular treatment (either in addition to or in lieu of IV tPA).
- Trevo Thrombectomy Procedure Device
Other Names: Trevo ProVue Retriever; Trevo XP ProVue Retriever Intervention Desc: stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot) ARM 1: Kind: Experimental Label: Trevo Thrombectomy Procedure Description: Trevo Thrombectomy Procedure and Medical Management
- Medical Management Other
Other Names: Standard of Care Intervention Desc: Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc ARM 1: Kind: Experimental Label: Trevo Thrombectomy Procedure Description: Trevo Thrombectomy Procedure and Medical Management ARM 2: Kind: Experimental Label: Medical Management Description: Medical Management
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Weighted modified Rankin Scale (mRS) score||90 days||No|
|Primary||Stroke-related mortality||90 days||Yes|
|Secondary||Good functional outcome||90 days||No|
|Secondary||Early response||5-7 Days||No|
|Secondary||All cause mortality||90 days||Yes|
|Secondary||Median final infarct size||24 hours||No|
|Secondary||Revascularization rates||24 hours||No|
|Secondary||Vessel reperfusion rates||Immediately after device usage and at the end of the thrombectomy procedure||No|
|Secondary||Symptomatic intracranial hemorrhage||24 hours||Yes|
|Secondary||Neurological deterioration from baseline NIHSS score||5-7 days||Yes|
|Secondary||Procedure-related and device-related SAEs||24 hours||Yes|
|Primary||Weighted modified Rankin Scale (mRS) score, Lead Co-Primary Efficacy Outcome||90 days|
|Primary||Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome||90 days|
|Primary||Stroke-related mortality, Primary Safety Outcome||90 days|