Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry

Active, not recruiting

Phase N/A Results N/A

Trial Description

The purpose of this registry is to assess clinical outcomes, and different factors that may affect these clinical outcomes such as systems of care, associated with the use of Covidien market-released neurothrombectomy devices intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion.

Detailed Description

This is a prospective, multi-center, non-randomized, observational registry of acute ischemic stroke patients that have or will undergo treatment with the use of a Covidien market-released neurothrombectomy device (as the initial device used to remove the thrombus) within 8 hours of stroke symptom onset, at the discretion of the investigator and independent of participation in this registry. This registry may enroll up to 1000 patients.

Conditions

Trial Design

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

Trial Population

Acute Ischemic Stroke Patients

Outcomes

Type Measure Time Frame Safety Issue
Primary Status of revascularization at the end of the interventional procedure Day 0 No
Secondary Symptomatic intracranial hemorrhage 1 day No
Secondary Incidence of Neurological Events of Interest up to 90 days post index procedure

Sponsors