Trevo® Retriever Registry Post Market Surveillance

Ischemic Stroke Clinical Trial

Official title:

Stryker Neurovascular Trevo® Retriever Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040259
• Other study ID #: T4025
• Status: Completed
• Start date: November 25, 2013
• Est. completion date: December 28, 2017

Study information

• Verified date: June 2020
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2008
• Est. completion date: December 28, 2017
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto
Czechia	University Hospital Hradec Králové	Hradec Králové
France	CHU Bordeaux	Bordeaux
France	Hôpital Henri Mondor	Creteil
France	GRENOBLE	Grenoble
France	CHU Lille	Lille
France	Hopital Dupuytren	Limoges
France	CHU Nancy	Nancy
France	La Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	La Pitié Salpêtrière	Paris
France	CHU de Tours	Tours
Germany	Klinikum Augsburg	Augsburg
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	Klinikum Dortmund	Dortmund
Germany	Uniklinik Erlangen	Erlangen
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Uniklinik Heidelberg	Heidelberg
Germany	Uniklinik Homburg	Homburg/ Saar
Germany	UKSH; Lübeck	Lubeck
Germany	Uniklinik Mainz- Mainz	Mainz-GE
Hungary	National Institute of Clinical Neurosciences	Budapest
Italy	Spedali Civili di Brescia	Brescia
Italy	Ospedale San Martino	Genova
Korea, Republic of	Kyungpook National University Hospital	Jungni I Gu
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Singapore	National Neuroscience Institute,	Singapore
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario De La Princesa	Madrid
Spain	Hospital Universitario Central De Asturias	Oviedo
Spain	Son Espases de Mallorca	Palma de Mallorca
Spain	Hospital Universitario Donostia	San Sebastian
Switzerland	Kantonsspital Aarau	Aarau
Thailand	Siriraj Hospital	Bangkok
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Mission Hospital	Asheville	North Carolina
United States	Emory University at Grady Memorial Hospital	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Buffalo General Medical Center	Buffalo	New York
United States	Eden Medical Center	Castro Valley	California
United States	Erlanger Hospital	Chattanooga	Tennessee
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Riverside Methodist Hospital/ Ohio Health Research Institute	Columbus	Ohio
United States	McLaren Flint Regional Medical Center	Flint	Michigan
United States	St. Jude Medical Center	Fullerton	California
United States	Valley Baptist Harlingen	Harlingen	Texas
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Houston Methodist Hospital	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Baptist Medical Center - Jacksonville	Jacksonville	Florida
United States	University of Tennessee Medical Center Knoxville	Knoxville	Tennessee
United States	Scripps Memorial Hospital	La Jolla	California
United States	Baptist Health Lexington	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	UCLA Medical Center	Los Angeles	California
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Methodist Healthcare - Memphis Hospitals	Memphis	Tennessee
United States	Banner Desert Medical Center	Mesa	Arizona
United States	University of Miami (Jackson Memorial)	Miami	Florida
United States	Yale University / Yale-New Haven Hospital	New Haven	Connecticut
United States	Mount Sinai Health System	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	UCI Medical Center	Orange	California
United States	Florida Hospital	Orlando	Florida
United States	Advocate Christ Lutheran Hospital	Park Ridge	Illinois
United States	Peoria Radiology Research & Education Foundation	Peoria	Illinois
United States	Drexel University	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)	Phoenix	Arizona
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	St. Joseph Mercy	Pontiac	Michigan
United States	Maine Medical Center	Portland	Maine
United States	Oregon Stroke Center, Oregon Health & Science University (OHSU)	Portland	Oregon
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	California Pacific Medical Center (CPMC)	San Francisco	California
United States	Good Samaritan Hospital Regional Medical Center	San Jose	California
United States	Los Robles Hospital and Medical Center	Thousand Oaks	California
United States	Capital Health System	Trenton	New Jersey
United States	Center for Advanced Research Excellence (St. Mary's Medical Center)	West Palm Beach	Florida
United States	UMass Memorial	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Singapore,  Spain,  Switzerland,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score	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	Post Procedure
Secondary	Modified Rankin Scale (mRS) Assessment at 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.; - No significant disability despite symptoms; able to carry out all usual duties and activities.; - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.; - Moderate disability; requiring some help, but able to walk without assistance.; - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.; - Severe disability; bedridden, incontinent and requiring constant nursing care and attention.; - Dead.	90 days
Secondary	All Cause Mortality	Overall mortality rate	90 days
Secondary	Device and Procedure Related Serious Adverse Events (SAEs)	Rate of Device and Procedure related serious adverse events (SAE)	90 days
Secondary	Neurological Deterioration at 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.	24 hours