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

July 13, 2015 updated by: Stryker Neurovascular

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • Christian Doppler Clinic
  • Germany
      • Gottingen, Germany
        • Universitätsklinik Göttingen
      • Kiel, Germany
        • University Hospital Schleswig-Holstein Campus Kiel
      • Munich, Germany
        • Technische Universität München
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain
        • Hospital Universitari Germans Trias i Pujols
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Names:
  • Trevo Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90-day
Mortality at 90 Days
Time Frame: 90-day
All cause mortality through 90 days post procedure.
90-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (ESTIMATE)

March 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DQR0036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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