Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo "DAWN"

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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).

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors