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Trevo® Retriever Registry Post Market Surveillance

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ClinicalTrials.gov Identifier: NCT02040259
Recruitment Status : Completed
First Posted : January 20, 2014
Results First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Study Description
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Brief Summary:
The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

Condition or disease
Ischemic Stroke

Detailed Description:

Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, multi-center, international registry that may enroll a maximum of 2000 patients at up to 100 sites worldwide. Revascularization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in Cerebral Infarction)score. Additional data collection will include:

  1. Day 90 mRS assessment
  2. Day 90 all cause mortality
  3. Neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the NIHSS score from the baseline score
  4. Rates of device and procedure related serious adverse events (AEs)
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 2008 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Stryker Neurovascular Trevo® Retriever Registry
Study Start Date : November 25, 2013
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Groups and Cohorts
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Group/Cohort
Mechanical thrombectomy, Trevo Retriever
Mechanical thrombectomy, Trevo Retriever


Outcome Measures
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Primary Outcome Measures :
  1. Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score [ Time Frame: Post Procedure ]

    The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure.

    Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (< 50%) of the entire vascular territory is visualized.

    Grade 2b - Filling of > 50% all of the expected vascular territory is visualized, but the filling is slower than normal.

    Grade 3 - Complete Perfusion



Secondary Outcome Measures :
  1. Modified Rankin Scale (mRS) Assessment at 90 Days [ Time Frame: 90 days ]

    The Modified Rankin Scale mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

    A good clinical outcome = mRS scale 0-2. 0 - No symptoms at all.

    1. - No significant disability despite symptoms; able to carry out all usual duties and activities.
    2. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.
    3. - Moderate disability; requiring some help, but able to walk without assistance.
    4. - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
    5. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention.
    6. - Dead.

  2. All Cause Mortality [ Time Frame: 90 days ]
    Overall mortality rate

  3. Device and Procedure Related Serious Adverse Events (SAEs) [ Time Frame: 90 days ]
    Rate of Device and Procedure related serious adverse events (SAE)

  4. Neurological Deterioration at 24 Hours [ Time Frame: 24 hours ]
    Neurological Deterioration at 24 hours post procedure, defined as a 4 point or more increase in the NIHSS score over the baseline score.


Eligibility Criteria
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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:   Probability Sample
Study Population
Acute ischemic stroke patients who may be referred for mechanical thrombectomy is used to removed thrombus in the neurovasculature
Criteria

Inclusion Criteria:

  • Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
  • Trevo Retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus
  • Signed Informed Consent obtained
  • Subject willing to comply with the protocol follow-up requirements
  • Anticipated life expectancy of at least 3 months

Exclusion Criteria:

  • The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point.
Contacts and Locations
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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): NCT02040259


Locations
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Sponsors and Collaborators
Stryker Neurovascular
Investigators
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Principal Investigator: Erol Veznedaroglu, MD Drexel Neurosciences Institute,Philadelphia
Principal Investigator: Ronald Budzik, MD Riverside Methodist Hospital/ Ohio Health Research Institute, Columbus, OH
  Study Documents (Full-Text)

Documents provided by Stryker Neurovascular:
Study Protocol  [PDF] March 24, 2016
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02040259    
Other Study ID Numbers: T4025
First Posted: January 20, 2014    Key Record Dates
Results First Posted: June 24, 2020
Last Update Posted: June 24, 2020
Last Verified: June 2020
Keywords provided by Stryker Neurovascular:
ischemic stroke
mechanical thrombectomy device
Retriever
Additional relevant MeSH terms:
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Ischemic Stroke
Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases