Trevo® Retriever Registry Post Market Surveillance

NCT02040259 | Completed Results

• 1 other identifier: T4025
• Study Type: observational
• Target: 2,008
• Locations: 12 countries
• Sites: 80

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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke; mechanical thrombectomy device; Retriever

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Modified Rankin Scale (mRS) Assessment at 90 Days

  90 days

• All Cause Mortality

  90 days

• Device and Procedure Related Serious Adverse Events (SAEs)

  90 days

• Neurological Deterioration at 24 Hours

  24 hours

Study Arms (1)

Mechanical thrombectomy, Trevo Retriever

Mechanical thrombectomy, Trevo Retriever

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (80)

Banner Desert Medical Center

Mesa, Arizona, 85202, United States

Location

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

Phoenix, Arizona, 85013, United States

Location

Eden Medical Center

Castro Valley, California, 94546, United States

Location

St. Jude Medical Center

Fullerton, California, 92835, United States

Location

Scripps Memorial Hospital

La Jolla, California, 92037, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UCI Medical Center

Orange, California, 92868, United States

Location

California Pacific Medical Center (CPMC)

San Francisco, California, 94114, United States

Location

Good Samaritan Hospital Regional Medical Center

San Jose, California, 95124, United States

Location

Los Robles Hospital and Medical Center

Thousand Oaks, California, 91360, United States

Location

Yale University / Yale-New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Baptist Medical Center - Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of Miami (Jackson Memorial)

Miami, Florida, 33126, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

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

West Palm Beach, Florida, 33409, United States

Location

Emory University at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

WellStar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Advocate Christ Lutheran Hospital

Park Ridge, Illinois, 60068, United States

Location

Peoria Radiology Research & Education Foundation

Peoria, Illinois, 61637, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

UMass Memorial

Worcester, Massachusetts, 01655, United States

Location

McLaren Flint Regional Medical Center

Flint, Michigan, 48532, United States

Location

St. Joseph Mercy

Pontiac, Michigan, 48341, United States

Location

Capital Health System

Trenton, New Jersey, 08638, United States

Location

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital/ Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

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

Portland, Oregon, 97239, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Erlanger Hospital

Chattanooga, Tennessee, 37377, United States

Location

University of Tennessee Medical Center Knoxville

Knoxville, Tennessee, 37920, United States

Location

Methodist Healthcare - Memphis Hospitals

Memphis, Tennessee, 38120, United States

Location

Valley Baptist Harlingen

Harlingen, Texas, 78550, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Toronto Western Hospital

Toronto, M5T 2S8, Canada

Location

University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

Location

CHU Bordeaux

Bordeaux, 33000, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

GRENOBLE

Grenoble, 38700, France

Location

CHU Lille

Lille, 59037, France

Location

Hopital Dupuytren

Limoges, 59037, France

Location

CHU Nancy

Nancy, 54035, France

Location

La Pitié Salpêtrière

Paris, 75013, France

Location

La Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

CHU de Tours

Tours, 37044, France

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

Klinikum Dortmund

Dortmund, 44137, Germany

Location

Uniklinik Erlangen

Erlangen, 91504, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Uniklinik Heidelberg

Heidelberg, 69120, Germany

Location

Uniklinik Homburg

Homburg/ Saar, 66421, Germany

Location

UKSH; Lübeck

Lübeck, 23538, Germany

Location

Uniklinik Mainz- Mainz

Mainz-GE, 55101, Germany

Location

National Institute of Clinical Neurosciences

Budapest, 1145, Hungary

Location

Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Ospedale San Martino

Genova, 16132, Italy

Location

National Neuroscience Institute,

Singapore, 308433, Singapore

Location

Kyungpook National University Hospital

Jungni I Gu, 700-721, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, 20014, Spain

Location

Hospital Universitario De La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Central De Asturias

Oviedo, 33006, Spain

Location

Son Espases de Mallorca

Palma de Mallorca, 7120, Spain

Location

Kantonsspital Aarau

Aarau, 5000, Switzerland

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (2)

• Bartolini B, Krajina A, Budzik R, Gupta R, Nogueira RG, Malek A, Sarraj A, English J, Narata AP, Taqi M, Miller T, Grobelny T, Baxter B, Jenkins P, Liebeskind DS, Veznedaroglu E; Trevo Registry Investigators. Outcomes of Mechanical Thrombectomy of Acute Basilar Artery Occlusion Due to Underlying Intracranial Atherosclerotic Disease. Stroke Vasc Interv Neurol. 2022 Nov 18;3(2):e000429. doi: 10.1161/SVIN.122.000429. eCollection 2023 Mar.

  PMID: 41585922 DERIVED

• 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.

  PMID: 33430634 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Minyi Ji, Biostatistician, Clinical Evidence
• Organization: Stryker Neurovascular

minyi.ji@stryker.com

+1 (510) 980-5689

Study Officials

• Erol Veznedaroglu, MD

  Drexel Neurosciences Institute,Philadelphia

  PRINCIPAL INVESTIGATOR

• Ronald Budzik, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 20, 2014
• Study Start: November 25, 2013
• Primary Completion: December 28, 2017
• Study Completion: December 28, 2017
• Last Updated: June 24, 2020
• Results First Posted: June 24, 2020

Record last verified: 2020-06

Locations

SG (1); ES (5); KR (2); DE (9); IT (2); HU (1); FR (9); CH (1); US (47); TH (1); CA (1); CZ (1)