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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02239640
First Posted: September 15, 2014
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 8, 2014
First Posted: September 15, 2014
Last Update Posted: November 13, 2017
Last Verified: April 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