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Phase 4 N=60 Treatment

Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)

Ischemic Stroke

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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