We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 14 for:    trevo
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01088672
First Posted: March 17, 2010
Last Update Posted: July 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stryker Neurovascular
  Purpose

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: 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)

Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • 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]



Secondary Outcome Measures:
  • 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.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - 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.


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
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
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 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
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Stryker Neurovascular
Investigators
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT01088672     History of Changes
Other Study ID Numbers: DQR0036
First Submitted: March 15, 2010
First Posted: March 17, 2010
Results First Submitted: February 12, 2015
Results First Posted: July 17, 2015
Last Update Posted: July 17, 2015
Last Verified: July 2015

Keywords provided by Stryker Neurovascular:
Stroke
Ischemic
Thrombus
Embolectomy
Thrombectomy
Concentric
Embolus
Mechanical
Trevo

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia