Solitaire FR Thrombectomy for Acute Revascularisation "STAR"

Active, not recruiting

Phase N/A Results N/A

Trial Description

The purpose of this observational clinical evaluation is to evaluate the safety and efficacy of the Solitaire FR Device in subjects requiring mechanical thrombectomy when used according to its Instruction For Use (IFU), in real life practice.

Conditions

Trial Design

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

Trial Population

Patients presenting acute ischemic stroke with mechanical thrombectomy treatment deemed appropriate. Consecutive evaluation.

Outcomes

Type Measure Time Frame Safety Issue
Primary Arterial recanalization of the occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI) score equal or superior to 2b following the use of the Study Device. Immediately post procedure (day 1) No
Secondary Rate of device-related and procedure related Serious Adverse Events (SAEs) as a measure of safety. At hospital discharge or at 10 days post procedure if patient not discharged. Yes
Secondary Time to revascularisation Post procedure No

Sponsors