Trevo® Retriever Registry Post Market Surveillance

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Stryker Neurovascular
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT02040259
First received: January 15, 2014
Last updated: April 29, 2014
Last verified: January 2014
  Purpose

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
Ischemic Stroke

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Stryker Neurovascular Trevo® Retriever Registry

Resource links provided by NLM:


Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mRS assessment [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Assess the rate of participants with mRS </=2 to determine good clinial outcomes at 90 days.


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


Estimated Enrollment: 300
Study Start Date: November 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mechanical thrombectomy, Trevo Retriever
Mechanical thrombectomy, Trevo Retriever

Detailed Description:

Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, multi-center, international registry that may enroll a maximum of 300 patients at up to 40 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)
  Eligibility

Genders Eligible for Study:   Both
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
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: NCT02040259

Contacts
Contact: Paula P Schmidt, RN 510.413.2177 paula.schmidt@stryker.com

Locations
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94114
Contact: Joey English, MD    415-600-1163    joeyenglish@gmail.com   
Contact: Warren Kim, MD    415.600.7765    kimwt@sutterhealth.org   
Principal Investigator: Joey English, MD         
Sub-Investigator: Warren Kim, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Tim Miller, MD    410-328-5112    tmiller5@umm.edu   
Principal Investigator: Tim Miller, MD         
United States, New Jersey
Capital Health System Recruiting
Trenton, New Jersey, United States, 08638
Contact: Mandy J Binning, MD    609-394-6287    mbinning@capitalhealth.org   
Principal Investigator: Mandy J Binning, MD         
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Ciaran Powers    614-293-0689    ciaran.powers@osumc.edu   
Principal Investigator: Ciaran Powers, MD         
Riverside Methodist Hospital/ Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Ronald Budzik    614-566-1250    rbudzik@riversiderad.com   
Contact: Peter Pema    614.566.1250    ppema@riversiderad.com   
Principal Investigator: Ronald Budzik, MD         
Sub-Investigator: Peter Pema, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Qaisar Shah    215-481-3145    qshah@amh.org   
Contact: Osman Kozak    215.481.3145    okozak@amh.org   
Principal Investigator: Qaisar Shah, MD         
Sub-Investigator: Osman Kozak, MD         
United States, Tennessee
Erlanger Hospital Recruiting
Chattanooga, Tennessee, United States, 37377
Contact: Blaise Baxter    423-778-7234    bbaxter27@comcast.net   
Contact: Steven Quarfordt    423.778.7234    stevedq5@yahoo.com   
Principal Investigator: Blaise Baxter, MD         
Sub-Investigator: Steven Quarfordt, MD         
University of Tennessee Medical Center Knoxville Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Andrew Ferrell, MD    865-712-7210    andrewsferrell@gmail.com   
Contact: Jennifer Henry    865-305-8046    jhenry@mc.utmck.edu   
Principal Investigator: Andrew Ferrell, MD         
Sub-Investigator: Peter Kvamme, MD         
Methodist Healthcare - Memphis Hospitals Recruiting
Memphis, Tennessee, United States, 38120
Contact: Lucas Elijovich, MD    901-522-7767    lelijovich@semmes-murphey.com   
Contact: Hani Rashed    901-522-7767    hani.rashed@mlh.org   
Principal Investigator: Lucas Elijovich, MD         
Sub-Investigator: Adam Arthur, MD         
Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Erol Veznedaroglu, MD Capital Health System, Trenton, NJ
Principal Investigator: Ronald Budzik, MD Riverside Methodist Hospital/ Ohio Health Research Institute, Columbus, OH
  More Information

No publications provided

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02040259     History of Changes
Other Study ID Numbers: T4025
Study First Received: January 15, 2014
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ischemia
Stroke
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014