Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry "PRIISM2"

Active, not recruiting

Phase N/A Results N/A

Trial Description

To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients

Detailed Description

To determine the revascularization rate, clinical efficacy and safety in a "real-world setting" of the CE-marked MindFrame System in ischemic stroke patients with thrombotic neurovascular occlusions caused by an embolus deemed appropriate for endovascular treatment. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.

Conditions

Interventions

  • Mechanical Thrombectomy (Merci Retriever)Device
    Other Names: Penumbra system; TREVO; Solitaire
    Intervention Desc: Mechanical thrombectomy using a MindFrame device
    ARM 1: Kind: Experimental
    Label: Treatment Group
    Description: Subjects in whom a MindFrame Device was employed for restoration of flow and clot removal

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

The purpose of this registry is to compile data in a "real world setting". All subjects in whom there is an attempt to use the device will be included in the registry. All subjects must be recruited according to the Mindframe System "Instructions For Use".

Outcomes

Type Measure Time Frame Safety Issue
Primary Procedural Efficacy Immediate postprocedure No
Primary Safety 90 days postprocedure Yes
Primary Clinical Efficacy 90 days postprocedure No

Sponsors