Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke (TREVO2)
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ClinicalTrials.gov Identifier: NCT01270867 |
Recruitment Status :
Completed
First Posted : January 5, 2011
Results First Posted : February 27, 2014
Last Update Posted : August 3, 2015
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Condition or disease | Intervention/treatment | Phase |
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Ischemic Stroke | Device: Mechanical Thrombectomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 178 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2) |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
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Active Comparator: Merci Retriever
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.
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Device: Mechanical Thrombectomy
Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device. |
Experimental: Trevo Stentriever
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.
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Device: Mechanical Thrombectomy
Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device. |
- Primary Efficacy Endpoint [ Time Frame: acute/procedural ]
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]
- Primary Safety Endpoint [ Time Frame: within 24 hours of procedure ]Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).
- Secondary Endpoint [ Time Frame: 90 days ]
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.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead. https://en.wikipedia.org/wiki/Modified_Rankin_Sca
- Secondary Endpoint [ Time Frame: procedure through 90 days ]All cause mortality at 90 days
- Secondary Endpoint [ Time Frame: 24 hours ]Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
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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
Key Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270867
United States, Oregon | |
Oregon Health Sciences University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | 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 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Stryker Neurovascular |
ClinicalTrials.gov Identifier: | NCT01270867 |
Other Study ID Numbers: |
DQR0038 |
First Posted: | January 5, 2011 Key Record Dates |
Results First Posted: | February 27, 2014 |
Last Update Posted: | August 3, 2015 |
Last Verified: | July 2015 |
Ischemia Stroke Ischemic Stroke Mechanical Thrombectomy Brain |
Brain clot Cerebrovascular disease Recanalization Revascularization |
Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |