ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

Suspended

Phase N/A Results N/A

Trial Description

The ReStore™ Thrombectomy device restores blood flow in the neurovascular by removing thrombus in patients experiencing ischemic stroke. Patients enrolled in the ReStore Trial will be randomized to treatment with the ReStore™ Thrombectomy Device (investigational treatment) or to treatment with a commercially available thrombectomy device It is expected that the investigational treatment safety profile in terms of clinically significant procedural adverse events will be comparable to the control group.

Detailed Description

The objective of this study is to demonstrate substantial equivalence of the ReStore™ Thrombectomy Device with the legally marketed MERCI Retrieval System. The study will evaluate safety and efficacy of the ReStore™ Thrombectomy Device in subjects diagnosed with acute ischemic stroke who require mechanical thrombectomy. All eligible patients will be enrolled and randomized to treatment with either the investigational therapy or the control therapy.

Trial Stopped: DSMB recommendation to suspend trial due to control device

Conditions

Interventions

  • Thrombectomy (ReStore or Merci) Device
    Other Names: Mechanical Thrombectomy
    Intervention Desc: Each arm will use either ReStore or Merci as the primary thrombectomy device
    ARM 1: Kind: Experimental
    Label: Concentric Thrombectomy Catheter
    Description: Control Arm
    ARM 2: Kind: Experimental
    Label: Reverse ReStore mechanical thrombectomy
    Description: Reverse ReStore Device mechanical thrombectomy Each arm will use either ReStore or Merci as the primary thrombectomy device

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 The Primary efficacy endpoint is the achievement of revascularization in the targeted region post-procedure. The primary safety endpoint is the observed rate of clinically significant procedural complications occurring within 24 hours. 90 days Yes
Secondary mortality 30 and 90 days Yes

Sponsors