Ischemic StrokeNCT02040259
Trevo® Retriever Registry Post Market Surveillance
An observational study of Ischemic Stroke, run by Stryker Neurovascular at 80 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke
- How many people
- 2,008 participants
- Where
- 80 sitesin 12 countries
- Study dates
- 25 Nov 2013to 28 Dec 2017
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute ischemic stroke patients who may be referred for mechanical thrombectomy is used to removed thrombus in the neurovasculature
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
80 sites in 12 countries.
80 sites in 12 countries
United States47 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Mission Hospital
Asheville, North Carolina, 28801
Emory University at Grady Memorial Hospital
Atlanta, Georgia, 30303
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21287
Buffalo General Medical Center
Buffalo, New York, 14203
Eden Medical Center
Castro Valley, California, 94546
Erlanger Hospital
Chattanooga, Tennessee, 37377
Ohio State University Medical Center
Columbus, Ohio, 43210
Riverside Methodist Hospital/ Ohio Health Research Institute
Columbus, Ohio, 43214
McLaren Flint Regional Medical Center
Flint, Michigan, 48532
St. Jude Medical Center
Fullerton, California, 92835
Valley Baptist Harlingen
Harlingen, Texas, 78550
Memorial Regional Hospital
Hollywood, Florida, 33021
Houston Methodist Hospital
Houston, Texas, 77030
Memorial Hermann Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Baptist Medical Center - Jacksonville
Jacksonville, Florida, 32207
University of Tennessee Medical Center Knoxville
Knoxville, Tennessee, 37920
Scripps Memorial Hospital
La Jolla, California, 92037
Baptist Health Lexington
Lexington, Kentucky, 40503
University of Kentucky
Lexington, Kentucky, 40536
UCLA Medical Center
Los Angeles, California, 90095
WellStar Kennestone Hospital
Marietta, Georgia, 30060
Methodist Healthcare - Memphis Hospitals
Memphis, Tennessee, 38120
Banner Desert Medical Center
Mesa, Arizona, 85202
University of Miami (Jackson Memorial)
Miami, Florida, 33126
Yale University / Yale-New Haven Hospital
New Haven, Connecticut, 06520
Mount Sinai Health System
New York, New York, 10029
Christiana Hospital
Newark, Delaware, 19718
UCI Medical Center
Orange, California, 92868
Florida Hospital
Orlando, Florida, 32803
Advocate Christ Lutheran Hospital
Park Ridge, Illinois, 60068
Peoria Radiology Research & Education Foundation
Peoria, Illinois, 61637
Drexel University
Philadelphia, Pennsylvania, 19107
St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)
Phoenix, Arizona, 85013
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
St. Joseph Mercy
Pontiac, Michigan, 48341
Maine Medical Center
Portland, Maine, 04102
Oregon Stroke Center, Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
California Pacific Medical Center (CPMC)
San Francisco, California, 94114
Good Samaritan Hospital Regional Medical Center
San Jose, California, 95124
Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360
Capital Health System
Trenton, New Jersey, 08638
Center for Advanced Research Excellence (St. Mary's Medical Center)
West Palm Beach, Florida, 33409
UMass Memorial
Worcester, Massachusetts, 01655
France9 sites
CHU Bordeaux
Bordeaux, 33000
Hôpital Henri Mondor
Créteil, 94000
GRENOBLE
Grenoble, 38700
CHU Lille
Lille, 59037
Hopital Dupuytren
Limoges, 59037
CHU Nancy
Nancy, 54035
La Pitié Salpêtrière
Paris, 75013
La Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
CHU de Tours
Tours, 37044
Germany9 sites
Klinikum Augsburg
Augsburg, 86156
Vivantes Klinikum Neukölln
Berlin, 12351
Klinikum Dortmund
Dortmund, 44137
Uniklinik Erlangen
Erlangen, 91504
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Uniklinik Heidelberg
Heidelberg, 69120
Uniklinik Homburg
Homburg/ Saar, 66421
UKSH; Lübeck
Lübeck, 23538
Uniklinik Mainz- Mainz
Mainz-GE, 55101
Spain5 sites
Hospital Universitario Donostia
Donostia / San Sebastian, 20014
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario De La Princesa
Madrid, 28006
Hospital Universitario Central De Asturias
Oviedo, 33006
Son Espases de Mallorca
Palma de Mallorca, 7120
Italy2 sites
Spedali Civili di Brescia
Brescia, 25123
Ospedale San Martino
Genova, 16132
South Korea2 sites
Kyungpook National University Hospital
Jungni I Gu, 700-721
Seoul National University Bundang Hospital
Seongnam-si, 463-707
About this study
Official title: Stryker Neurovascular Trevo® Retriever Registry
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.
Read the 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:
- Day 90 mRS assessment
- Day 90 all cause mortality
- Neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the NIHSS score from the baseline score
- Rates of device and procedure related serious adverse events (AEs)
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, mechanical thrombectomy device, Retriever
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical thrombectomy, Trevo Retriever | Mechanical thrombectomy, Trevo Retriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post Procedure
Secondary outcomes (4)
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.
Measured: 90 days
All Cause Mortality
Overall mortality rate
Measured: 90 days
Device and Procedure Related Serious Adverse Events (SAEs)
Rate of Device and Procedure related serious adverse events (SAE)
Measured: 90 days
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study start25 Nov 2013
- Primary completion28 Dec 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,008 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erol Veznedaroglu, MD, Principal investigator, Drexel Neurosciences Institute,PhiladelphiaRonald Budzik, MD, Principal investigator, Riverside Methodist Hospital/ Ohio Health Research Institute, Columbus, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040259
- Sponsor's protocol ID
- T4025
- Status last verified
- Jun 2020
- First submitted
- 15 Jan 2014
- Last updated
- 24 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 41585922Nogueira 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.
PubMed 33430634
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stryker Neurovascular Trevo® Retriever Registry
- ClinicalTrials.gov ID
- NCT02040259
- Acronym / sponsor ID
- T4025
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, mechanical thrombectomy device, Retriever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,008 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2013
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Posted 24 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Day 90 mRS assessment
- Day 90 all cause mortality
- Neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the NIHSS score from the baseline score
- Rates of device and procedure related serious adverse events (AEs)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical thrombectomy, Trevo Retriever | – | –Mechanical thrombectomy, Trevo Retriever |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute ischemic stroke patients who may be referred for mechanical thrombectomy is used to removed thrombus in the neurovasculature
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score
Time frame: Post Procedure
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
4 secondary outcomes
Modified Rankin Scale (mRS) Assessment at 90 Days
Time frame: 90 days
All Cause Mortality
Time frame: 90 days
Device and Procedure Related Serious Adverse Events (SAEs)
Time frame: 90 days
Neurological Deterioration at 24 Hours
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41585922Bartolini 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.
- Derived from this study: PubMed 33430634Nogueira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erol Veznedaroglu, MD principal investigator
Drexel Neurosciences Institute,Philadelphia
Ronald Budzik, MD principal investigator
Riverside Methodist Hospital/ Ohio Health Research Institute, Columbus, OH
80 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Stryker Neurovascular at 80 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, France, Germany, Spain, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score (time frame: Post Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02040259, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.