NCT01088672

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

July 17, 2015

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

March 15, 2010

Results QC Date

February 12, 2015

Last Update Submit

July 13, 2015

Conditions

Ischemic Stroke

Keywords

StrokeIschemicThrombusEmbolectomyThrombectomyConcentricEmbolusMechanicalTrevo

Outcome Measures

Primary Outcomes (1)

  • Revascularization Status

    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 Outcomes (2)

  • Clinical Outcomes at 90 Days

    90-day

  • Mortality at 90 Days

    90-day

Study Arms (1)

Acute Ischemic Stroke

OTHER

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

Interventions

Mechanical ThrombectomyPROCEDURE

The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

Also known as: Trevo Procedure
Acute Ischemic Stroke

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Christian Doppler Clinic

Salzburg, Austria

Location

Universitätsklinik Göttingen

Göttingen, Germany

Location

University Hospital Schleswig-Holstein Campus Kiel

Kiel, Germany

Location

Technische Universität München

Munich, Germany

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari Germans Trias i Pujols

Barcelona, Spain

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (2)

  • Jansen O, Macho JM, Killer-Oberpfalzer M, Liebeskind D, Wahlgren N; TREVO Study Group. Neurothrombectomy for the treatment of acute ischemic stroke: results from the TREVO study. Cerebrovasc Dis. 2013;36(3):218-25. doi: 10.1159/000353990. Epub 2013 Oct 12.

    PMID: 24135533RESULT

  • Shi ZS, Liebeskind DS, Xiang B, Ge SG, Feng L, Albers GW, Budzik R, Devlin T, Gupta R, Jansen O, Jovin TG, Killer-Oberpfalzer M, Lutsep HL, Macho J, Nogueira RG, Rymer M, Smith WS, Wahlgren N, Duckwiler GR; Multi MERCI, TREVO, and TREVO 2 Investigators. Predictors of functional dependence despite successful revascularization in large-vessel occlusion strokes. Stroke. 2014 Jul;45(7):1977-84. doi: 10.1161/STROKEAHA.114.005603. Epub 2014 May 29.

    PMID: 24876082DERIVED

MeSH Terms

Conditions

Ischemic StrokeStrokeIschemiaThrombosisEmbolism

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and Thrombosis

Results Point of Contact

Title
Amelia Saliba, AIS Clinical Program Manager
Organization
Stryker NV
aisstudies@stryker.com
510-413-2500

Study Officials

  • Nils Wahlgren, MD

    Karolinska University Hospital in Solna

    PRINCIPAL INVESTIGATOR

  • Olav Jansen, MD

    Universitätsklinikum Schleswig-Holstein - Campus Kiel UK S-H

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2010

First Posted

March 17, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

July 17, 2015

Results First Posted

July 17, 2015

Record last verified: 2015-07

Locations

ES(2)AU(1)DE(3)SE(1)