Trevo® Retriever Registry Post Market Surveillance

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Stryker Neurovascular
Information provided by (Responsible Party):
Stryker Neurovascular Identifier:
First received: January 15, 2014
Last updated: August 19, 2014
Last verified: August 2014

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.

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

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)
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)

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


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 identifier: NCT02040259

Contact: Paula P Schmidt, RN 510.413.2177

United States, California
St. Jude Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: Hamed Farid, MD    714-992-3000 ext x2680   
Contact: Pam Kuhns    714-213-9498   
Principal Investigator: Hamed Farid, MD         
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94114
Contact: Joey English, MD    415-600-1163   
Contact: Warren Kim, MD    415.600.7765   
Principal Investigator: Joey English, MD         
Sub-Investigator: Warren Kim, MD         
United States, Connecticut
Yale University / Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Ketan Bulsara, MD    203-737-2096   
Contact: Janet Halliday    203-785-4146   
Principal Investigator: Ketan Bulsara, MD         
Sub-Investigator: Joseph Schindler, MD         
United States, Georgia
WellStar Kennestone Hospital Recruiting
Marietta, Georgia, United States, 30060
Contact: Rishi Gupta, MD    770-422-2326   
Contact: Ahmad Khaldi, MD    770-422-2326   
Principal Investigator: Rishi Gupta, MD         
Sub-Investigator: Ahmad Khaldi, MD         
United States, Illinois
Advocate Christ Lutheran Hospital Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Thomas Grobelny, md    847-430-6108   
Contact: Gina Littlejohn, RN    847-723-8200   
Sub-Investigator: Scott Geraghty, MD         
Principal Investigator: Thomas Grobelny, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Tim Miller, MD    410-328-5112   
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   
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   
Principal Investigator: Ciaran Powers, MD         
Riverside Methodist Hospital/ Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Ronald Budzik    614-566-1250   
Contact: Peter Pema    614.566.1250   
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   
Contact: Osman Kozak    215.481.3145   
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   
Contact: Steven Quarfordt    423.778.7234   
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   
Contact: Jennifer Henry    865-305-8046   
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   
Contact: Hani Rashed    901-522-7767   
Principal Investigator: Lucas Elijovich, MD         
Sub-Investigator: Adam Arthur, MD         
United States, Washington
Multi-Care/St. Joseph's (Tacoma General Hospital) Recruiting
Tacoma, Washington, United States, 98405
Contact: Brian Kott, MD    253-284-0841   
Contact: Meredith Barnhart    253-403-7258   
Principal Investigator: Brian Kott, MD         
Sub-Investigator: Dennis Wang, MD         
Hospital Universitario Central De Asturias Recruiting
Oviedo, Spain, 33006
Contact: Pedro Vega, MD    0034 985108000   
Contact: Eduardo Murias, MD    34.985.108.000   
Principal Investigator: Pedro Vega, MD         
Sub-Investigator: Eduardo Murias, MD         
Sponsors and Collaborators
Stryker Neurovascular
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 Identifier: NCT02040259     History of Changes
Other Study ID Numbers: T4025
Study First Received: January 15, 2014
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stryker Neurovascular:
ischemic stroke
mechanical thrombectomy device
Retriever processed this record on September 22, 2014