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Trevo® Retriever Registry Post Market Surveillance

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ClinicalTrials.gov Identifier: NCT02040259
Recruitment Status : Active, not recruiting
First Posted : January 20, 2014
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Type : Observational [Patient Registry]
Actual Enrollment : 2010 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Stryker Neurovascular Trevo® Retriever Registry
Study Start Date : November 2013
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 2017
Groups and Cohorts

Group/Cohort
Mechanical thrombectomy, Trevo Retriever
Mechanical thrombectomy, Trevo Retriever


Outcome Measures

Primary Outcome Measures :
  1. Revascularization status assessment at the end of the Trevo Retriever procedure using the modified TICI score [ Time Frame: Modified TICI score assess at the end of the procedure ]

Secondary Outcome Measures :
  1. mRS assessment [ Time Frame: 90 days ]
    Assess the rate of participants with mRS </=2 to determine good clinical outcomes at 90 days.


Other Outcome Measures:
  1. Assess the rates of device and procedure related serious adverse events (AEs) [ Time Frame: 90 days ]
  2. Assess all cause mortality [ Time Frame: 90 days ]
    Report if cause of death is device or procedure related.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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

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


  Show 80 Study Locations
Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Erol Veznedaroglu, MD Drexel Neurosciences Institute,Philadelphia
Principal Investigator: Ronald Budzik, MD Riverside Methodist Hospital/ Ohio Health Research Institute, Columbus, OH
More Information

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02040259     History of Changes
Other Study ID Numbers: T4025
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: May 2017

Keywords provided by Stryker Neurovascular:
ischemic stroke
mechanical thrombectomy device
Retriever