Clinical trial NCT01270867: Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke
Official title: Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: Ischemia
Stroke
Ischemic Stroke
Mechanical Thrombectomy
Brain
Brain clot
Cerebrovascular disease
Recanalization
Revascularization
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2011-01-05
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: acute/procedural
measure: Primary Safety Endpoint
timeFrame: within 24 hours of procedure
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: 90 days
measure: Secondary Endpoint
timeFrame: procedure through 90 days
measure: Secondary Endpoint
timeFrame: 24 hours
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
affiliation: Emory University
name: Raul G Nogueira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Helmi Lutsep, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Wade Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.