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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239640
• Other study ID #: NV-SFR005
• Status: Completed
• Start date: August 21, 2014
• Est. completion date: October 7, 2016

Study information

• Verified date: March 2019
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 984
• Est. completion date: October 7, 2016
• Est. primary completion date: October 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Buffalo General Medical Center	Buffalo	New York
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Cleveland Clinic	Cleveland	Ohio
United States	OhioHealth Riverside Methodist Hospital	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Geisinger Clinic	Danville	Pennsylvania
United States	Advanced Neuroscience Network/Tenet South Florida	Delray Beach	Florida
United States	St. John Providence Hospital, Detroit	Detroit	Michigan
United States	McLaren Flint	Flint	Michigan
United States	Valley Baptist Medical Center	Harlingen	Texas
United States	South Broward Hospital	Hollywood	Florida
United States	Memorial Hermann Texas Medical Center	Houston	Texas
United States	Methodist Hospital, Houston	Houston	Texas
United States	University of California Irvine	Irvine	California
United States	St. Dominic's - Jackson Memorial Hospital	Jackson	Mississippi
United States	Baptist Medical Center - Jacksonville	Jacksonville	Florida
United States	Presence St. Joseph Medical Center	Joliet	Illinois
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Baptist Health Lexington/Central Baptist	Lexington	Kentucky
United States	University of Kentucky Hospital	Lexington	Kentucky
United States	University of California Los Angeles	Los Angeles	California
United States	Baptist Hospital Louisville	Louisville	Kentucky
United States	Norton Healthcare	Louisville	Kentucky
United States	WellStar Kennestone Regional Medical Center	Marietta	Georgia
United States	Baptist Hospital of Miami	Miami	Florida
United States	University of Miami Hospital	Miami	Florida
United States	Aurora Hospital, Milwaukee	Milwaukee	Wisconsin
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	West Virginia University/ Ruby Memorial	Morgantown	West Virginia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Florida Hospital	Orlando	Florida
United States	Banner University Medical Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Oregon Health and Science University Hospital	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Mayo Clinic, Rochester	Rochester	Minnesota
United States	Mercy San Juan Medical Center/ Mercy General	Sacramento	California
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	California Pacific Medical Center	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Crouse Hospital	Syracuse	New York
United States	Los Robles Medical Center	Thousand Oaks	California
United States	ProMedica Toledo Hospital	Toledo	Ohio
United States	University of Arizona Medical Center	Tucson	Arizona
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause Mortality		up to 90 days post index procedure
Other	Number of Participants With Good Functional Outcome (mRS 0-2)	Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke.; Clasiffication: 0 - No symptoms.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead. (lower values represent less disability)	90 days post index procedure
Other	Incidence of Device Related Serious Adverse Events	Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.	up to 90 days post index procedure
Other	Time to Revascularization	Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa.	Day 0-At the completion of the thrombectomy procedure
Other	Incidence of Procedure Related Serious Adverse Events	Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.	up to 90 days post index procedure
Primary	Number of Participants Assessed for Revascularization With mTICI Grades 2b-3	Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches.; Classification: grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes)	Day 0-At the completion of the thrombectomy procedure
Secondary	Incidence of Neurological Events of Interest	Evaluate events causing neurological deterioration (defined as = 4 worsening points from baseline on the NIHSS scale)	up to 90 days post index procedure