RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study "REDIRECT"

Recruiting

Phase N/A Results N/A

Trial Description

Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent retriever) with Solitaire FR within 8 hours of stroke onset caused by the large vessel occlusion.

Detailed Description

RECO is a novel, self-expanding stent retriever, designed to yield rapid flow restoration in acute cerebral ischaemia. The proposed study is a multicenter, randomized, prospective, parallel-group, open-label clinical trial with a blinded outcome, to test the RECO(a novel, self-expanding stent retriever), as compared with Solitaire FR stent retriever.

Conditions

Interventions

  • RECO flow restoration device Device
    Other Names: RECO
    Intervention Desc: RECO flow restoration device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.
    ARM 1: Kind: Experimental
    Label: IA thrombolysis
    Description: IA thrombolysis is executed by RECO flow restoration device which is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.
    ARM 2: Kind: Experimental
    Label: IA thrombectomy
    Description: IA thrombectomy is executed by RECO flow restoration device which is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.
    ARM 3: Kind: Experimental
    Label: RECO thrombectomy
    Description: IA thrombectomy is executed by RECO flow restoration device which is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.
  • T-PA Drug
    Other Names: Alteplase
    Intervention Desc: intavenous recombinat tissue plasminogen activator
    ARM 1: Kind: Experimental
    Label: intravenous t-PA
    Description: intravenous t-PA for stroke within 4.5h of symptom onset
  • Solitaire FR flow restoration device Device
    Other Names: Solitaire FR
    Intervention Desc: Solitaire FR flow restoration device has been approved by the FDA and CFDA.
    ARM 1: Kind: Experimental
    Label: Solitaire FR thrombectomy
    Description: IA thrombectomy is executed by Solitaire FR flow restoration device

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Primary Efficacy Endpoint 90 days No
Secondary mortality procedure through 90 days Yes
Secondary intracranial hemorrhages 24 hours Yes
Secondary NIHSS 24 hours and 7days No
Secondary Revascularzation of the occluded territoty acute/procedural No
Primary Revascularization Status Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment No
Secondary Clinical Outcomes at 90 Days 90-day No
Secondary all-cause mortality at 90 days procedure through 90 days No

Sponsors