Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO) "TREVO"

Completed

Phase 4 Results

Trial Description

To determine the revascularization rate of the CE-marked Trevo device in large vessel occlusions in ischemic stroke patients.
- Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure.

Detailed Description

- Clinical outcomes at 90 days
- Mortality at 90 days
- Device-related serious adverse events (DRSAEs)
- Symptomatic ICH rate within 24 (-6/+12) hours post-procedure

Conditions

Interventions

  • Mechanical Thrombectomy (Merci Retriever)Device
    Other Names: Penumbra system; TREVO; Solitaire
    Intervention Desc: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
    ARM 1: Kind: Experimental
    Label: Acute Ischemic Stroke patients
    Description: Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are candidates for mechanical embolectomy.
    ARM 2: Kind: Experimental
    Label: Acute Ischemic Stroke
    Description: Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are candidates for mechanical embolectomy, will be enrolled in trial. Patients will be evaluated for symptoms of ICH during first 24 hours. Patients will be evaluated for primary and secondary outcomes at 90 days post procedure.

Outcomes

Type Measure Time Frame Safety Issue
Primary Revascularization status. Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure
Secondary Clinical outcomes at 90 days; Mortality at 90 days; Device-related serious adverse events (DRSAEs); Symptomatic ICH rate within 24.
Primary Revascularization status Post-procedure No
Secondary Clinical outcomes at 90 days 90-day No
Secondary Mortality at 90 days 90-day No
Secondary Device-related serious adverse events (DRSAEs) Procedure Yes
Secondary Symptomatic ICH rate within 24 (-6/+12 hours) post-procedure Post procedure through 24 hours (-6/+12) Yes

Sponsors