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Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke (TREVO2)
This study has been completed.
Sponsor:
Stryker Neurovascular
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT01270867
First received: January 4, 2011
Last updated: July 13, 2015
Last verified: July 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| Ischemic Stroke | Device: Mechanical Thrombectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2) |
Further study details as provided by Stryker Neurovascular:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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
| Enrollment: | 178 |
| Study Start Date: | February 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
Device: Mechanical Thrombectomy
Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.
|
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."
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
-
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01270867
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270867
Locations
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97239 | |
Sponsors and Collaborators
Stryker Neurovascular
Investigators
| 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 |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stryker Neurovascular |
| ClinicalTrials.gov Identifier: | NCT01270867 History of Changes |
| Other Study ID Numbers: |
DQR0038 |
| Study First Received: | January 4, 2011 |
| Results First Received: | November 20, 2013 |
| Last Updated: | July 13, 2015 |
Keywords provided by Stryker Neurovascular:
|
Ischemia Stroke Ischemic Stroke Mechanical Thrombectomy Brain |
Brain clot Cerebrovascular disease Recanalization Revascularization |
Additional relevant MeSH terms:
|
Stroke Ischemia Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on June 23, 2017