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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Medtronic Neurovascular Clinical Affairs

ClinicalTrials.gov Identifier:

NCT02239640

First received: September 8, 2014

Last updated: April 14, 2017

Last verified: April 2017

History of Changes

Purpose

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.

Condition
Ischemic Stroke


Study Type:	Observational [Patient Registry]
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration:	90 Days
Official Title:	Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry

Further study details as provided by Medtronic Neurovascular Clinical Affairs:

Primary Outcome Measures:

Status of revascularization at the end of the interventional procedure [ Time Frame: Day 0 ]
Assess revascularization using Thrombolysis in Cerebral Infarction (TICI) score at the end of the procedure

Secondary Outcome Measures:

Incidence of Neurological Events of Interest [ Time Frame: up to 90 days post index procedure ]
Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)

Other Outcome Measures:

All-cause mortality [ Time Frame: up to 90 days post index procedure ]
Functional and Neurological Deficit [ Time Frame: Discharge & 90 days ]
Evaluate mRS and NIHSS
Incidence of device and procedure related serious adverse events [ Time Frame: up to 90 days post index procedure ]
Time to Revascularization [ Time Frame: Day 0 ]


Estimated Enrollment:	1000
Study Start Date:	August 2014
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Acute Ischemic Stroke Patients

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02239640

Show 55 Study Locations

Sponsors and Collaborators

Medtronic Neurovascular Clinical Affairs

Investigators


Principal Investigator:	Nils Mueller-Kronast, M.D.	Advanced Neuroscience Network/Tenet South Florida

More Information


Responsible Party:	Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier:	NCT02239640 History of Changes
Other Study ID Numbers:	NV-SFR005
Study First Received:	September 8, 2014
Last Updated:	April 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	Only multi center data will be available

Additional relevant MeSH terms:


Stroke Ischemia Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia

ClinicalTrials.gov processed this record on August 23, 2017

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