Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT01088672
First received: March 15, 2010
Last updated: April 25, 2014
Last verified: October 2012
  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: 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)

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
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088672

Locations
Spain
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
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

Additional Information:
No publications provided by Stryker Neurovascular

Additional 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
Study First Received: March 15, 2010
Last Updated: April 25, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

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

ClinicalTrials.gov processed this record on November 24, 2014