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Ischemic StrokeTREVO2NCT01270867

Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke

A study testing Mechanical Thrombectomy in people with Ischemic Stroke, run by Stryker Neurovascular at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Ischemic Stroke
What is being tested?
Mechanical Thrombectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteUnited States
Study dates
Feb 2011to Mar 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health Sciences University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2)

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.

Read the detailed description

The TREVO 2 protocol was designed to assess the safety and effectiveness of the Trevo Retriever device and determine if it is substantially equivalent to the predicate Merci Retriever. The trial utilized a Primary Effectiveness Endpoint of revascularization and a composite Primary Safety Endpoint that included procedure-related serious adverse events occurring within 24 hours of the procedure. Subjects who presented to enrolling centers with large ischemic strokes were screened for eligibility in the study. If a subject met eligibility criteria, then Informed Consent was obtained prior to commencing the angiogram. If all inclusion/exclusion criteria were confirmed, including the angiographic criteria, then the subject was randomized.The Primary Effectiveness Endpoint was successful revascularization of the target occlusion, using the TICI score. Success was determined by the central Core Lab.The Primary Safety Endpoint is a composite endpoint, described in the protocol as the "Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours) defined as: vascular perforation or intramural arterial dissection, symptomatic ICH, embolization to a previously uninvolved territory, access site complication requiring surgical repair or blood transfusion, intra-procedural mortality, device failure (in vivo breakage), or any other complications judged by the Clinical Events Committee (CEC) to be related to the procedure."

Conditions
Ischemic Stroke
Being tested
Mechanical Thrombectomy
Keywords
Ischemia, Stroke, Ischemic Stroke, Mechanical Thrombectomy, Brain, Brain clot, Cerebrovascular disease, Recanalization, Revascularization
Medical subject headings
Ischemic Stroke, Ischemia, Stroke, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mechanical ThrombectomyDevice

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

Study groups in NCT01270867
Study groupRoleWhat they receive
Merci RetrieverActive comparatorMerci 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.
Receives: Device: Mechanical Thrombectomy
Trevo StentrieverExperimentalTrevo 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.
Receives: Device: Mechanical Thrombectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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]

    Measured: acute/procedural

  2. Primary Safety Endpoint

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

    Measured: within 24 hours of procedure

Secondary outcomes (3)

  1. Secondary Endpoint

    Good clinical outcomes at 90 days, as assessed by mRS (a "good" clinical outcome is defined as mRS </= 2)

    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_Sca

    Measured: 90 days

  2. Secondary Endpoint

    All cause mortality at 90 days

    Measured: procedure through 90 days

  3. Secondary Endpoint

    Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionDec 2011
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01270867
Sponsor's protocol ID
DQR0038
Acronym
TREVO2
Status last verified
Jul 2015
First submitted
4 Jan 2011
Last updated
3 Aug 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22932714

  • 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.

    PubMed 29089415

  • 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.

    PubMed 24876082

Questions about this trial

What is this clinical trial studying?

A study testing Mechanical Thrombectomy in people with Ischemic Stroke, run by Stryker Neurovascular at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Endpoint (time frame: acute/procedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01270867, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.

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