Ischemic StrokePhase 4TREVONCT01088672
Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
A Phase 4 study testing Mechanical Thrombectomy in people with Ischemic Stroke, run by Stryker Neurovascular at 7 sites in 4 countries.
Trial summary
To determine the revascularization rate of the CE-marked Trevo device in large vessel occlusions in ischemic stroke patients. Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Mechanical Thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Feb 2010to Nov 2011
- Phase
- Phase 4
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-79 (has had 18th birthday, but not yet had 80th birthday)
- NIHSS 8 - 30
- Anticipated life expectancy of at least 6 months
- No significant pre-stroke disability (mRS less than or equal to 1)
- Written informed consent to participate given by patient or legal representative
- Angiographic confirmation of a persistent large vessel occlusion, in the internal carotid, middle cerebral M1 and/or M2 segments, basilar or vertebral arteries
- Treatable within 8 hours of symptom onset, defined as the first pass being made with the Trevo device.
Who cannot join
- Baseline glucose of < 50 mg/dL (2.78 mmol) or > 400 mg / dL (22.20 mmol)
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- Treated with Heparin within 48 hours with a PTT greater than 2 times the lab normal
- Baseline platelet count < 30,000
- History of severe allergy (more than rash) to contrast medium
- Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication (i.e. Nipride), the patient can be enrolled
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- Woman of child bearing potential who is known to be pregnant
- Patient participating in another clinical study or protocol
- For anterior circulation strokes: strokes involving greater than 1/3 of the MCA territory, as determined by hypodensity on the baseline non- contrast CT, or low CBV on CT Perfusion imaging, or restricted diffusion on DWI images
- For posterior circulation strokes within the midbrain and/or pons, extensive hypodensity on the baseline CT, or low CBV on CT Perfusion imaging, or extensive restricted diffusion on DWI images
- Baseline CT/MR evidence of significant mass effect with midline shift
- Baseline CT/MR evidence of hemorrhage
- Baseline CT/MR evidence of intracranial tumor (except small meningioma)
- Angiographic evidence of vasculitis or arterial dissection
- High grade stenosis that cannot be treated safely or which prevents access to the thrombus with the Trevo device
- Angiographic evidence of excessive arterial tortuosity that precludes the Trevo device from reaching the thrombus
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Germany3 sites
Universitätsklinik Göttingen
Göttingen
University Hospital Schleswig-Holstein Campus Kiel
Kiel
Technische Universität München
Munich
Spain2 sites
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Universitari Germans Trias i Pujols
Barcelona
About this study
To determine the revascularization rate of the CE-marked Trevo device in large vessel occlusions in ischemic stroke patients.
- Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure.
Read the detailed description
- Clinical outcomes at 90 days
- Mortality at 90 days
- Device-related serious adverse events (DRSAEs)
- Symptomatic ICH rate within 24 (-6/+12) hours post-procedure
- Conditions
- Ischemic Stroke
- Being tested
- Mechanical Thrombectomy
- Keywords
- Stroke, Ischemic, Thrombus, Embolectomy, Thrombectomy, Concentric, Embolus, Mechanical, Trevo
- Medical subject headings
- Ischemic Stroke, Stroke, Ischemia, Thrombosis, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ThrombectomyProcedure or surgery
Also called Trevo Procedure
The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
| Study group | Role | What they receive |
|---|---|---|
| Acute Ischemic Stroke | Other | Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke Receives: Procedure: Mechanical Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revascularization Status
Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure
Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.
Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...
Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]
Measured: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
Secondary outcomes (2)
Clinical Outcomes at 90 Days
Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days.
mRS 0-2 indicates functional independence 0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead. https://en.wikipedia.org/wiki/Modified_Rankin_Scale
Measured: 90-day
Mortality at 90 Days
All cause mortality through 90 days post procedure.
Measured: 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionNov 2011
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nils Wahlgren, MD, Principal investigator, Karolinska University Hospital in SolnaOlav Jansen, MD, Principal investigator, Universitätsklinikum Schleswig-Holstein - Campus Kiel UK S-H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088672
- Sponsor's protocol ID
- DQR0036
- Acronym
- TREVO
- Status last verified
- Jul 2015
- First submitted
- 15 Mar 2010
- Last updated
- 17 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jansen O, Macho JM, Killer-Oberpfalzer M, Liebeskind D, Wahlgren N; TREVO Study Group. Neurothrombectomy for the treatment of acute ischemic stroke: results from the TREVO study. Cerebrovasc Dis. 2013;36(3):218-25. doi: 10.1159/000353990. Epub 2013 Oct 12.
PubMed 24135533Shi ZS, Liebeskind DS, Xiang B, Ge SG, Feng L, Albers GW, Budzik R, Devlin T, Gupta R, Jansen O, Jovin TG, Killer-Oberpfalzer M, Lutsep HL, Macho J, Nogueira RG, Rymer M, Smith WS, Wahlgren N, Duckwiler GR; Multi MERCI, TREVO, and TREVO 2 Investigators. Predictors of functional dependence despite successful revascularization in large-vessel occlusion strokes. Stroke. 2014 Jul;45(7):1977-84. doi: 10.1161/STROKEAHA.114.005603. Epub 2014 May 29.
PubMed 24876082
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
- ClinicalTrials.gov ID
- NCT01088672
- Acronym / sponsor ID
- TREVO / DQR0036
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Ischemic, Thrombus, Embolectomy, Thrombectomy, Concentric, Embolus, Mechanical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Posted 17 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the revascularization rate of the CE-marked Trevo device in large vessel occlusions in ischemic stroke patients.
- Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure.
Detailed description
- Clinical outcomes at 90 days
- Mortality at 90 days
- Device-related serious adverse events (DRSAEs)
- Symptomatic ICH rate within 24 (-6/+12) hours post-procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Ischemic Stroke | Other | Procedure: Mechanical ThrombectomySingle arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-79 (has had 18th birthday, but not yet had 80th birthday)
- NIHSS 8 - 30
- Anticipated life expectancy of at least 6 months
- No significant pre-stroke disability (mRS less than or equal to 1)
- Written informed consent to participate given by patient or legal representative
Key exclusion criteria (16 listed)
- Baseline glucose of < 50 mg/dL (2.78 mmol) or > 400 mg / dL (22.20 mmol)
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- Treated with Heparin within 48 hours with a PTT greater than 2 times the lab normal
- Baseline platelet count < 30,000
- History of severe allergy (more than rash) to contrast medium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ThrombectomyAlso: Trevo ProcedureThe Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. | Procedure or surgery | Acute Ischemic Stroke |
Primary outcome
Revascularization Status
Time frame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized. Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ... Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]
2 secondary outcomes
Clinical Outcomes at 90 Days
Time frame: 90-day
Mortality at 90 Days
Time frame: 90-day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24135533Jansen O, Macho JM, Killer-Oberpfalzer M, Liebeskind D, Wahlgren N; TREVO Study Group. Neurothrombectomy for the treatment of acute ischemic stroke: results from the TREVO study. Cerebrovasc Dis. 2013;36(3):218-25. doi: 10.1159/000353990. Epub 2013 Oct 12.
- Derived from this study: PubMed 24876082Shi ZS, Liebeskind DS, Xiang B, Ge SG, Feng L, Albers GW, Budzik R, Devlin T, Gupta R, Jansen O, Jovin TG, Killer-Oberpfalzer M, Lutsep HL, Macho J, Nogueira RG, Rymer M, Smith WS, Wahlgren N, Duckwiler GR; Multi MERCI, TREVO, and TREVO 2 Investigators. Predictors of functional dependence despite successful revascularization in large-vessel occlusion strokes. Stroke. 2014 Jul;45(7):1977-84. doi: 10.1161/STROKEAHA.114.005603. Epub 2014 May 29.
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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.
Nils Wahlgren, MD principal investigator
Karolinska University Hospital in Solna
Olav Jansen, MD principal investigator
Universitätsklinikum Schleswig-Holstein - Campus Kiel UK S-H
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mechanical Thrombectomy in people with Ischemic Stroke, run by Stryker Neurovascular at 7 sites in 4 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 7 inclusion and 16 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 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Spain, Austria, Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2015). 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 (time frame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment). 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 NCT01088672, 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 17 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.