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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:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier:
NCT02239640
First received: September 8, 2014
Last updated: August 11, 2016
Last verified: August 2016
  Purpose
The purpose of this registry is to assess outcomes associated with the use of devices intended to restore blood flow in patients experiencing acute ischemic stroke.

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:
  • Symptomatic intracranial hemorrhage [ Time Frame: 90 days ]
    Evaluate the rate of participants with symptomatic intracranial hemorrhage post procedure and up to 90 days


Other Outcome Measures:
  • All-cause mortality [ Time Frame: 90 days ]

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 registry evaluating the use of devices in patients diagnosed with an acute ischemic stroke. 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:

  • An informed consent or waiver
  • Patient has experienced an acute ischemic stroke
  • Treatment within 8 hours of stroke onset

Exclusion Criteria:

  • Concurrent participation in a 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

Locations
United States, Florida
Delray Medical Center
Delray Beach, Florida, United States, 33484
United States, Kentucky
Neurosurgical Associates at Central Baptist
Lexington, Kentucky, United States, 40503
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
Principal Investigator: Nils Mueller-Kronast, M.D. Delray Medical Center
  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: August 11, 2016
Individual Participant Data  
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 March 22, 2017