Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO) (TREVO)
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ClinicalTrials.gov Identifier: NCT01088672 |
Recruitment Status :
Completed
First Posted : March 17, 2010
Results First Posted : July 17, 2015
Last Update Posted : July 17, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ischemic Stroke | Procedure: Mechanical Thrombectomy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO) |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
Acute Ischemic Stroke
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
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Procedure: Mechanical Thrombectomy
The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Other Name: Trevo Procedure |
- 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]
- Clinical Outcomes at 90 Days [ Time Frame: 90-day ]
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
- Mortality at 90 Days [ Time Frame: 90-day ]All cause mortality through 90 days post procedure.

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088672
Austria | |
Christian Doppler Clinic | |
Salzburg, Austria | |
Germany | |
Universitätsklinik Göttingen | |
Gottingen, Germany | |
University Hospital Schleswig-Holstein Campus Kiel | |
Kiel, Germany | |
Technische Universität München | |
Munich, Germany | |
Spain | |
Hospital Clínic de Barcelona | |
Barcelona, Spain, 08036 | |
Hospital Universitari Germans Trias i Pujols | |
Barcelona, Spain | |
Sweden | |
Karolinska University Hospital | |
Stockholm, Sweden |
Principal Investigator: | Nils Wahlgren, MD | Karolinska University Hospital in Solna | |
Principal Investigator: | Olav Jansen, MD | Universitätsklinikum Schleswig-Holstein - Campus Kiel UK S-H |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Stryker Neurovascular |
ClinicalTrials.gov Identifier: | NCT01088672 |
Other Study ID Numbers: |
DQR0036 |
First Posted: | March 17, 2010 Key Record Dates |
Results First Posted: | July 17, 2015 |
Last Update Posted: | July 17, 2015 |
Last Verified: | July 2015 |
Stroke Ischemic Thrombus Embolectomy Thrombectomy |
Concentric Embolus Mechanical Trevo |
Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |