- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01270867
Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke (TREVO2)
Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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] |
acute/procedural
|
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).
|
within 24 hours of procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
90 days
|
Secondary Endpoint
Time Frame: procedure through 90 days
|
All cause mortality at 90 days
|
procedure through 90 days
|
Secondary Endpoint
Time Frame: 24 hours
|
Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Helmi Lutsep, MD, Oregon Health and Science University
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: Lancet. 2012 Oct 6;380(9849):1230.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DQR0038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemic Stroke
-
Nordsjaellands HospitalRigshospitalet, Denmark; Metropolitan University CollegeCompletedTransient Ischemic Attack | Stroke, Ischemic | Stroke HemorrhagicDenmark
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Second Affiliated Hospital, School of Medicine,...Shanghai Zhongshan Hospital; First Affiliated Hospital of Wenzhou Medical University and other collaboratorsRecruitingAcute Ischemic Stroke and Transient Ischemic AttacksChina
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic Bakken Research CenterCompletedCryptogenic Symptomatic Transient Ischemic Attack | Cryptogenic Ischemic StrokeNetherlands, United States, France, Belgium, Germany, Sweden, Italy, Austria, Canada, Denmark, Finland, Greece, Slovakia, Spain
-
Umbria Bioengineering TechnologiesRecruitingStroke, Ischemic | Stroke HemorrhagicItaly
-
University Hospital, BrestCompletedStroke, Ischemic | Stroke HemorrhagicFrance
-
BayerRecruitingAcute Non-cardioembolic Ischemic Stroke | Prevention of Ischemic Stroke | High-risk Transient Ischemic AttackUnited States, Switzerland, Belgium, Australia, Sweden, Canada, Taiwan, Spain, Korea, Republic of, Latvia, Israel, Malaysia, China, Greece, Japan, Turkey, Netherlands, Romania, United Kingdom, Portugal, Hungary, Italy, Brazil, France, S... and more
-
Sheffield Teaching Hospitals NHS Foundation TrustUnknownFatigue | Stroke, Ischemic | Stroke HemorrhagicUnited Kingdom
-
University of AlbertaCompletedTransient Ischemic Attack | Minor Ischemic StrokeCanada
-
Stephanie HarrisonActive, not recruitingTransient Ischemic Attack | Stroke, IschemicUnited Kingdom
Clinical Trials on Mechanical Thrombectomy
-
ThrombX MedicalNot yet recruitingIschemic Stroke
-
phenox Inc.CompletedIschemia | Pathologic Processes | Cardiovascular Diseases | Vascular Diseases | Cerebrovascular Disorders | Brain Diseases | Central Nervous System Diseases | Nervous System Diseases | Stroke, Ischemic | Stroke, AcuteUnited States, Germany
-
Paul J. GagneRecruitingAcute Deep Venous Thrombosis of Ileofemoral VeinUnited States
-
SurModics, Inc.RecruitingPeripheral Arterial Disease | Acute Limb IschemiaUnited States
-
Capital Medical UniversityNot yet recruitingAcute Ischemic StrokeChina
-
Hospital Clinic of BarcelonaGermans Trias i Pujol Hospital; Hospital Universitario Ramon y Cajal; Hospital... and other collaboratorsRecruitingStroke | Thrombectomy | IschemicSpain
-
University Hospital, MontpellierRecruitingStroke | Large Vessel Occlusion | IschemicFrance
-
Stryker NeurovascularCompletedIschemic StrokeUnited States, Spain, France, Switzerland, Belgium, Canada, Czechia, Germany, Italy, Korea, Republic of, United Kingdom
-
University Hospital, MontpellierCompleted
-
The Cleveland ClinicCompletedAcute Ischemic StrokeUnited States