Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry
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| ClinicalTrials.gov Identifier: NCT02239640 |
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Recruitment Status :
Active, not recruiting
First Posted : September 15, 2014
Last Update Posted : April 18, 2017
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Sponsor:
Medtronic Neurovascular Clinical Affairs
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs
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Brief 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.
| Condition or disease |
|---|
| Ischemic Stroke |
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.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 1000 participants |
| 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 |
| Study Start Date : | August 2014 |
| Estimated Primary Completion Date : | December 2017 |
| Estimated Study Completion Date : | December 2018 |
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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| 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.
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medtronic Neurovascular Clinical Affairs |
| ClinicalTrials.gov Identifier: | NCT02239640 History of Changes |
| Other Study ID Numbers: |
NV-SFR005 |
| First Posted: | September 15, 2014 Key Record Dates |
| Last Update Posted: | April 18, 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:
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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 |