SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study "SWIFT"

Active, not recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.

Conditions

Interventions

  • SOLITAIRE™ Device compared to MERCI® Device Device
    Intervention Desc: SOLITAIRE™ Device (investigational device) compared with the commercially available device, MERCI® Device
    ARM 1: Kind: Experimental
    Label: SOLITAIRE™ Device
    Description: The SOLITAIRE™ Device (investigational device) is the experimental arm
    ARM 2: Kind: Experimental
    Label: MERCI® Device
    Description: The MERCI® Device (control device) is commercially available.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI)score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage. Immediately post treatment No
Secondary Time to initial recanalization Measurement of patient's neurological condition including NIH Stroke Scale, Barthel Index and Modified Rankin Score at 30 and 90 days post procedure Rate of morbidity and mortality Incidence of symptomatic hemorrhage 30 and 90 days post treatment No

Sponsors