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

Ischemic Stroke Clinical Trial

— TREVO2  

Official title:

Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270867
• Other study ID #: DQR0038
• Status: Completed
• Phase: N/A
• First received: January 4, 2011
• Last updated: July 13, 2015
• Start date: February 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2015
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Mechanical Thrombectomy
Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.

Locations

Country	Name	City	State
United States	Oregon Health Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint	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	No
Primary	Primary Safety Endpoint	Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).	within 24 hours of procedure	Yes
Secondary	Secondary Endpoint	Good clinical outcomes at 90 days, as assessed by mRS (a "good" clinical outcome is defined as mRS 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	90 days	No
Secondary	Secondary Endpoint	All cause mortality at 90 days	procedure through 90 days	Yes
Secondary	Secondary Endpoint	Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure	24 hours	Yes

External Links

•   American Stroke Association
•   Concentric Medical Website