NCT01270867

Brief Summary

To determine if the Trevo Retriever is as good or better than the Merci Retriever in restoring blood flow to the brain of a patient experiencing an acute ischemic stroke in a large vessel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 27, 2014

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

January 4, 2011

Results QC Date

November 20, 2013

Last Update Submit

July 13, 2015

Conditions

Ischemic Stroke

Keywords

IschemiaStrokeIschemic StrokeMechanical ThrombectomyBrainBrain clotCerebrovascular diseaseRecanalizationRevascularization

Outcome Measures

Primary Outcomes (2)

  • Primary Efficacy Endpoint

    Revascularization of the occluded territory, defined as at least TICI 2 flow in the treated territory after use of the assigned device. 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\[PubMed\]

    acute/procedural

  • Primary Safety Endpoint

    Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).

    within 24 hours of procedure

Secondary Outcomes (3)

  • Secondary Endpoint

    90 days

  • Secondary Endpoint

    procedure through 90 days

  • Secondary Endpoint

    24 hours

Study Arms (2)

Merci Retriever

ACTIVE COMPARATOR

Merci Retriever is the predicate product that received FDA clearance in 2004. Merci Retriever a first generation mechanical thrombectomy device intended to remove clot and restore blood flow in a neurovascular vessel in the setting of acute ischemic stroke.

Device: Mechanical Thrombectomy

Trevo Stentriever

EXPERIMENTAL

Trevo Retriever is a second generation mechanical thrombectomy device intended to remove clot and restore blood flow in a neurovascular vessel in the setting of acute ischemic stroke. The Trevo Retriever is a type of stent, specifically design to allow for clot integration into the device. The clot in the retriever is then removed and blood flow is restored.

Device: Mechanical Thrombectomy

Interventions

Mechanical ThrombectomyDEVICE

Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.

Merci RetrieverTrevo Stentriever

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient presenting with clinical signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, and:
  • Patient has failed IV t-PA therapy Or
  • Patient is contraindicated for IV t-PA administration
  • NIHSS 8 \< NIHSS \< 29
  • Anticipated life expectancy of at least 6 months
  • No significant pre-stroke disability (mRS \< 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 and/or vertebral arteries
  • Treatable within 8 hours of symptom onset, defined as the first pass being made with the assigned study device

You may not qualify if:

  • Abnormal blood pressure and/or blood coagulation lab values
  • Pregnancy
  • Patient participating in another investigational drug or device study
  • More than 1/3 of MCA or equivalent in non-MCA territory
  • Baseline evidence of significant mass effect with midline shift, or hemorrhage, or intracranial tumor
  • Bilateral stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Related Publications (3)

  • Nogueira RG, Lutsep HL, Gupta R, Jovin TG, Albers GW, Walker GA, Liebeskind DS, Smith WS; TREVO 2 Trialists. Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet. 2012 Oct 6;380(9849):1231-40. doi: 10.1016/S0140-6736(12)61299-9. Epub 2012 Aug 26.

    PMID: 22932714RESULT

  • Winningham MJ, Haussen DC, Nogueira RG, Liebeskind DS, Smith WS, Lutsep HL, Jovin TG, Xiang B, Nahab F. Periprocedural heparin use in acute ischemic stroke endovascular therapy: the TREVO 2 trial. J Neurointerv Surg. 2018 Jul;10(7):611-614. doi: 10.1136/neurintsurg-2017-013441. Epub 2017 Oct 31.

    PMID: 29089415DERIVED

  • 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

Related Links

MeSH Terms

Conditions

Ischemic StrokeIschemiaStrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Paula Schmidt, Clinical Project Manager
Organization
Concentric Medical / Stryker Neurovascular Inc
paula.schmidt@stryker.com
510-413-2271

Study Officials

  • Raul G Nogueira, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Helmi Lutsep, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Wade Smith, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 5, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

August 3, 2015

Results First Posted

February 27, 2014

Record last verified: 2015-07

Locations

US(1)