Overview

This trial is active, not recruiting.

Condition ischemic stroke
Sponsor Medtronic Neurovascular Clinical Affairs
Start date August 2014
End date December 2017
Trial size 1000 participants
Trial identifier NCT02239640, NV-SFR005

Summary

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Status of revascularization at the end of the interventional procedure
time frame: Day 0

Secondary Outcomes

Measure
Incidence of Neurological Events of Interest
time frame: up to 90 days post index procedure

Eligibility Criteria

All participants of any age.

Inclusion Criteria: - Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or IRB and/or local or institutional policies. - Patient has experienced an acute ischemic stroke due to large intracranial vessel occlusion (with associated symptoms) and has been or will be treated with a Covidien market-released neurothrombectomy device, as the initial device used to remove the thrombus. - Treatment within 8 hours of stroke onset. - Pre-Stroke Modified Rankin Scale (mRS) score ≤ 1 (immediately) prior to stroke onset. - Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30. Exclusion Criteria: - Concurrent participation in a multicenter randomized study.

Additional Information

Official title Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry
Principal investigator Nils Mueller-Kronast, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Medtronic Neurovascular Clinical Affairs.