Phase 4
N=60
Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01088672 ↗Enrolled (actual)
60
Serious AEs
20.0%
Results posted
Jul 2015
Primary outcome: Primary: Revascularization Status — 92 percentage of subjects TICI 2 or >
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mechanical Thrombectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Neurovascular
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Revascularization Status |
92 | — |
| SECONDARY Clinical Outcomes at 90 Days |
55 | — |
| SECONDARY Mortality at 90 Days |
12 | — |
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.
Eligibility Criteria
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 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 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
Data sourced from ClinicalTrials.gov (NCT01088672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.