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

This study has been completed.
Information provided by (Responsible Party):
Stryker Neurovascular Identifier:
First received: March 15, 2010
Last updated: October 23, 2012
Last verified: October 2012

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 Intervention Phase
Ischemic Stroke
Procedure: Mechanical Thrombectomy
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)

Resource links provided by NLM:

Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Revascularization status [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]
    Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure

Secondary Outcome Measures:
  • Clinical outcomes at 90 days [ Time Frame: 90-day ] [ Designated as safety issue: No ]
    Good clinical outcome is defined as an mRS score of 0-2 at 90 days. The change in NIHSS score between baseline and 90 days will also be used to assess clinical outcomes.

  • Mortality at 90 days [ Time Frame: 90-day ] [ Designated as safety issue: No ]
    All cause mortality through 90 days post procedure.

  • Device-related serious adverse events (DRSAEs) [ Time Frame: Procedure ] [ Designated as safety issue: Yes ]
    Vessel perforation or dissection attributable to the Trevo device, or cases where the Trevo device cannot be ruled out as the cause.

  • Symptomatic ICH rate within 24 (-6/+12 hours) post-procedure [ Time Frame: Post procedure through 24 hours (-6/+12) ] [ Designated as safety issue: Yes ]
    SITS-MOST and ECASS III definitions will be used. Symptomatic SAH (subarachnoid hemorrhage) will also be assessed.

Enrollment: 60
Study Start Date: February 2010
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Acute Ischemic Stroke patients
Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are candidates for mechanical embolectomy.
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

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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT01088672

Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Stryker Neurovascular
Principal Investigator: Nils Wahlgren, MD Karolinska University Hospital in Solna
Principal Investigator: Olav Jansen, MD Universitätsklinikum Schleswig-Holstein - Campus Kiel UK S-H
  More Information

Additional Information:
No publications provided

Responsible Party: Stryker Neurovascular Identifier: NCT01088672     History of Changes
Other Study ID Numbers: DQR0036
Study First Received: March 15, 2010
Last Updated: October 23, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Stryker Neurovascular:

Additional relevant MeSH terms:
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia processed this record on April 16, 2014