Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke - Full Text View

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 Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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
Secondary Endpoint [ Time Frame: procedure through 90 days ] [ Designated as safety issue: Yes ]
All cause mortality at 90 days
Secondary Endpoint [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Concentric Medical Website This link exits the ClinicalTrials.gov site

American Stroke Association This link exits the ClinicalTrials.gov site

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. Erratum in: Lancet. 2012 Oct 6;380(9849):1230.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Health Authority:	United States: Food and Drug Administration

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 September 23, 2016

Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke (TREVO2)