Trevo® Retriever Registry Post Market Surveillance

NCT ID: NCT02040259

Last Updated: 2020-06-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2008 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-25

Study Completion Date

2017-12-28

Brief Summary

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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

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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)

Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mechanical thrombectomy, Trevo Retriever

Mechanical thrombectomy, Trevo Retriever

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Neurovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erol Veznedaroglu, MD

Role: PRINCIPAL_INVESTIGATOR

Drexel Neurosciences Institute,Philadelphia

Ronald Budzik, MD

Role: PRINCIPAL_INVESTIGATOR

Riverside Methodist Hospital/ Ohio Health Research Institute, Columbus, OH

Locations

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Banner Desert Medical Center

Mesa, Arizona, United States

Site Status

St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)

Phoenix, Arizona, United States

Site Status

Eden Medical Center

Castro Valley, California, United States

Site Status

St. Jude Medical Center

Fullerton, California, United States

Site Status

Scripps Memorial Hospital

La Jolla, California, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

UCI Medical Center

Orange, California, United States

Site Status

California Pacific Medical Center (CPMC)

San Francisco, California, United States

Site Status

Good Samaritan Hospital Regional Medical Center

San Jose, California, United States

Site Status

Los Robles Hospital and Medical Center

Thousand Oaks, California, United States

Site Status

Yale University / Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Christiana Hospital

Newark, Delaware, United States

Site Status

Memorial Regional Hospital

Hollywood, Florida, United States

Site Status

Baptist Medical Center - Jacksonville

Jacksonville, Florida, United States

Site Status

University of Miami (Jackson Memorial)

Miami, Florida, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status

Center for Advanced Research Excellence (St. Mary's Medical Center)

West Palm Beach, Florida, United States

Site Status

Emory University at Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

WellStar Kennestone Hospital

Marietta, Georgia, United States

Site Status

Advocate Christ Lutheran Hospital

Park Ridge, Illinois, United States

Site Status

Peoria Radiology Research & Education Foundation

Peoria, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

UMass Memorial

Worcester, Massachusetts, United States

Site Status

McLaren Flint Regional Medical Center

Flint, Michigan, United States

Site Status

St. Joseph Mercy

Pontiac, Michigan, United States

Site Status

Capital Health System

Trenton, New Jersey, United States

Site Status

Buffalo General Medical Center

Buffalo, New York, United States

Site Status

Mount Sinai Health System

New York, New York, United States

Site Status

Vassar Brothers Medical Center

Poughkeepsie, New York, United States

Site Status

Mission Hospital

Asheville, North Carolina, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital/ Ohio Health Research Institute

Columbus, Ohio, United States

Site Status

Oregon Stroke Center, Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Drexel University

Philadelphia, Pennsylvania, United States

Site Status

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Site Status

Erlanger Hospital

Chattanooga, Tennessee, United States

Site Status

University of Tennessee Medical Center Knoxville

Knoxville, Tennessee, United States

Site Status

Methodist Healthcare - Memphis Hospitals

Memphis, Tennessee, United States

Site Status

Valley Baptist Harlingen

Harlingen, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

Memorial Hermann Hospital

Houston, Texas, United States

Site Status

Toronto Western Hospital

Toronto, , Canada

Site Status

University Hospital Hradec Králové

Hradec Králové, , Czechia

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

Hôpital Henri Mondor

Créteil, , France

Site Status

GRENOBLE

Grenoble, , France

Site Status

CHU Lille

Lille, , France

Site Status

Hopital Dupuytren

Limoges, , France

Site Status

CHU Nancy

Nancy, , France

Site Status

La Pitié Salpêtrière

Paris, , France

Site Status

La Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

CHU de Tours

Tours, , France

Site Status

Klinikum Augsburg

Augsburg, , Germany

Site Status

Vivantes Klinikum Neukölln

Berlin, , Germany

Site Status

Klinikum Dortmund

Dortmund, , Germany

Site Status

Uniklinik Erlangen

Erlangen, , Germany

Site Status

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status

Uniklinik Heidelberg

Heidelberg, , Germany

Site Status

Uniklinik Homburg

Homburg/ Saar, , Germany

Site Status

UKSH; Lübeck

Lübeck, , Germany

Site Status

Uniklinik Mainz- Mainz

Mainz-GE, , Germany

Site Status

National Institute of Clinical Neurosciences

Budapest, , Hungary

Site Status

Spedali Civili di Brescia

Brescia, , Italy

Site Status

Ospedale San Martino

Genova, , Italy

Site Status

National Neuroscience Institute,

Singapore, , Singapore

Site Status

Kyungpook National University Hospital

Jungni I Gu, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Universitario Donostia

Donostia / San Sebastian, , Spain

Site Status

Hospital Universitario De La Princesa

Madrid, , Spain

Site Status

Hospital Universitario Central De Asturias

Oviedo, , Spain

Site Status

Son Espases de Mallorca

Palma de Mallorca, , Spain

Site Status

Kantonsspital Aarau

Aarau, , Switzerland

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

Countries

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United States Canada Czechia France Germany Hungary Italy Singapore South Korea Spain Switzerland Thailand

References

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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.

Reference Type DERIVED
PMID: 33430634 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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T4025

Identifier Type: -

Identifier Source: org_study_id

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