N/A
N=178
Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01270867 ↗Enrolled (actual)
178
Serious AEs
44.9%
Results posted
Feb 2014
Primary outcome: Primary: Primary Efficacy Endpoint — 54; 76 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mechanical Thrombectomy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Neurovascular
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Endpoint |
54; 76 | — |
| PRIMARY Primary Safety Endpoint |
21; 13 | — |
| SECONDARY Secondary Endpoint |
48; 36 | — |
| SECONDARY Secondary Endpoint |
48; 36 | — |
| SECONDARY Secondary Endpoint |
48; 36 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01270867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.