Clinical trial NCT02040259: Trevo® Retriever Registry Post Market Surveillance
Official title: Stryker Neurovascular Trevo® Retriever Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: ischemic stroke
mechanical thrombectomy device
Retriever
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 2008
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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)

Eligibility 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.

Primary outcomes:
measure: Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score
timeFrame: Post Procedure
Secondary outcomes:
measure: Modified Rankin Scale (mRS) Assessment at 90 Days
timeFrame: 90 days
measure: All Cause Mortality
timeFrame: 90 days
measure: Device and Procedure Related Serious Adverse Events (SAEs)
timeFrame: 90 days
measure: Neurological Deterioration at 24 Hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Desert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)
state: Arizona
city: Castro Valley
country: United States
facility: Eden Medical Center
state: California
city: Fullerton
country: United States
facility: St. Jude Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center (CPMC)
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital Regional Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital and Medical Center
state: California
city: New Haven
country: United States
facility: Yale University / Yale-New Haven Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center - Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami (Jackson Memorial)
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: West Palm Beach
country: United States
facility: Center for Advanced Research Excellence (St. Mary's Medical Center)
state: Florida
city: Atlanta
country: United States
facility: Emory University at Grady Memorial Hospital
state: Georgia
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Park Ridge
country: United States
facility: Advocate Christ Lutheran Hospital
state: Illinois
city: Peoria
country: United States
facility: Peoria Radiology Research & Education Foundation
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial
state: Massachusetts
city: Flint
country: United States
facility: McLaren Flint Regional Medical Center
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy
state: Michigan
city: Trenton
country: United States
facility: Capital Health System
state: New Jersey
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital/ Ohio Health Research Institute
state: Ohio
city: Portland
country: United States
facility: Oregon Stroke Center, Oregon Health & Science University (OHSU)
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Hospital
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center Knoxville
state: Tennessee
city: Memphis
country: United States
facility: Methodist Healthcare - Memphis Hospitals
state: Tennessee
city: Harlingen
country: United States
facility: Valley Baptist Harlingen
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Toronto
country: Canada
facility: Toronto Western Hospital
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Králové
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Grenoble
country: France
facility: GRENOBLE
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: Hopital Dupuytren
city: Nancy
country: France
facility: CHU Nancy
city: Paris
country: France
facility: La Pitié Salpêtrière
city: Paris
country: France
facility: La Fondation Ophtalmologique Adolphe de Rothschild
city: Tours
country: France
facility: CHU de Tours
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Erlangen
country: Germany
facility: Uniklinik Erlangen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Heidelberg
country: Germany
facility: Uniklinik Heidelberg
city: Homburg/ Saar
country: Germany
facility: Uniklinik Homburg
city: Lubeck
country: Germany
facility: UKSH; Lübeck
city: Mainz-GE
country: Germany
facility: Uniklinik Mainz- Mainz
city: Budapest
country: Hungary
facility: National Institute of Clinical Neurosciences
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Genova
country: Italy
facility: Ospedale San Martino
city: Jungni I Gu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Singapore
country: Singapore
facility: National Neuroscience Institute,
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario De La Princesa
city: Oviedo
country: Spain
facility: Hospital Universitario Central De Asturias
city: Palma de Mallorca
country: Spain
facility: Son Espases de Mallorca
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Drexel Neurosciences Institute,Philadelphia
name: Erol Veznedaroglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Riverside Methodist Hospital/ Ohio Health Research Institute, Columbus, OH
name: Ronald Budzik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nogueira RG, Haussen DC, Liebeskind D, Jovin TG, Gupta R, Jadhav A, Budzik RF, Baxter B, Krajina A, Bonafe A, Malek A, Narata AP, Shields R, Zhang Y, Morgan P, Bartolini B, English J, Frankel MR, Veznedaroglu E; Trevo Registry and DAWN Trial Investigators. Stroke Imaging Selection Modality and Endovascular Therapy Outcomes in the Early and Extended Time Windows. Stroke. 2021 Jan;52(2):491-497. doi: 10.1161/STROKEAHA.120.031685. Epub 2021 Jan 12.