Ischemic Stroke
Conditions
Keywords
Ischemia, Stroke, Ischemic Stroke, Mechanical Thrombectomy, Brain, Brain clot, Cerebrovascular disease, Recanalization, Revascularization
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.
Interventions
DEVICEMechanical Thrombectomy
Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.
Sponsors
Stryker Neurovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint | 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 | within 24 hours of procedure | Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint | 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. 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Merci Retriever Patients who were randomized to the Merci Retriever | 90 |
| Trevo Stentriever Patients who were randomized to the Trevo Stentriever | 88 |
| Total | 178 |
Baseline characteristics
| Characteristic | Merci Retriever | Trevo Stentriever | Total |
|---|---|---|---|
| Age, Continuous | 67.0 years STANDARD_DEVIATION 14.7 | 67.4 years STANDARD_DEVIATION 13.9 | 67.2 years STANDARD_DEVIATION 14.2 |
| Region of Enrollment Spain | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 89 participants | 88 participants | 177 participants |
| Sex: Female, Male Female | 54 Participants | 48 Participants | 102 Participants |
| Sex: Female, Male Male | 36 Participants | 40 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 73 / 90 | 71 / 88 |
| serious Total, serious adverse events | 39 / 90 | 41 / 88 |
Outcome results
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\[PubMed\]
Time frame: acute/procedural
Population: Intent to treat analysis was performed. The non-inferiority hypothesis was tested with Blackwelder's method, assuming a one-sided alpha=0.025 and a clinically relevant non-inferiority margin of 10%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Merci Retriever | Primary Efficacy Endpoint | 54 participants |
| Trevo Stentriever | Primary Efficacy Endpoint | 76 participants |
Primary
Primary Safety Endpoint
Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).
Time frame: within 24 hours of procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Merci Retriever | Primary Safety Endpoint | 21 participants |
| Trevo Stentriever | Primary Safety Endpoint | 13 participants |
Secondary
Secondary Endpoint
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
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Merci Retriever | Secondary Endpoint | 19 participants |
| Trevo Stentriever | Secondary Endpoint | 34 participants |
Secondary
Secondary Endpoint
All cause mortality at 90 days
Time frame: procedure through 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Merci Retriever | Secondary Endpoint | 21 participants |
| Trevo Stentriever | Secondary Endpoint | 29 participants |
Secondary
Secondary Endpoint
Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Merci Retriever | Secondary Endpoint | 48 participants |
| Trevo Stentriever | Secondary Endpoint | 36 participants |