N/A
Completed N=201
Trevo® Retriever Registry (China)
Real World Data in China
Source: ClinicalTrials.gov NCT03554850 ↗
Enrolled (actual)
201
Serious AEs
5.5%
Results posted
Jan 2022
Primary outcomePrimary: the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure — 187 Participants
Summary
Trevo® Retriever Registry (China) is to assess real world performance of the FDA cleared Trevo Retriever intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke in China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure |
187 | — |
| SECONDARY Day 90 mRS |
148 | — |
| SECONDARY Day 90 Mortality |
11 | — |
| SECONDARY Neurological Deterioration |
15 | — |
| SECONDARY Rate of Study Device and Procedure Related SAE Through Day 90 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18
- Subjects experiencing acute ischemic stroke due to a large vessel occlusion who are eligible and suitable for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
- Trevo Retriever is planned to be the primary mechanical neuro-thrombectomy device to remove the thrombus
- Subject or subject's legally authorized Representative (LAR) has signed the study Informed Consent Form
- Subject willing to comply with the protocol follow-up requirements
Exclusion Criteria
- mRS >2
- Any known coagulopathy
- Anticipated life expectancy less than 3 months
- Known absolute contraindications to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, radiographic contrast agents, etc.)
- Preexisting neurological or psychiatric disease that would prevent complete the study required evaluations
- 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 (NCT03554850). 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.