N/A
Completed N=2,008
Trevo® Retriever Registry Post Market Surveillance
Source: ClinicalTrials.gov NCT02040259 ↗Enrolled (actual)
2,008
Serious AEs
21.3%
Results posted
Jun 2020
Primary outcomePrimary: Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score — 1863 Participants
Summary
The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score |
1863 | — |
| SECONDARY Modified Rankin Scale (mRS) Assessment at 90 Days |
1104 | — |
| SECONDARY All Cause Mortality |
280 | — |
| SECONDARY Device and Procedure Related Serious Adverse Events (SAEs) |
49 | — |
| SECONDARY Neurological Deterioration at 24 Hours |
97 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
- Trevo Retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus
- Signed Informed Consent obtained
- Subject willing to comply with the protocol follow-up requirements
- Anticipated life expectancy of at least 3 months
Exclusion Criteria
- The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point.
Data sourced from ClinicalTrials.gov (NCT02040259). 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. Informational only — not medical advice.