N/A
Completed N=183
Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia
Stroke, Acute
Source: ClinicalTrials.gov NCT03364023 ↗
Enrolled (actual)
183
Serious AEs
7.6%
Results posted
Aug 2020
Primary outcomePrimary: Modified Rankin Scale (mRS) at 90 Days — 112; 68 Participants
Summary
The purpose of this post-market registry is to collect real-world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Rankin Scale (mRS) at 90 Days |
112; 68 | — |
| SECONDARY Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure |
14 | — |
| SECONDARY All-Cause Mortality Through 90 Days Post Procedure |
14 | — |
| SECONDARY Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements.
- Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries.
- Subject has been or will be treated with a Medtronic market-released neurothrombectomy device as the initial device used to remove the thrombus.
- Subject is willing to participate in a 90-day follow-up visit.
- Treatment within 8 hours of stroke symptom onset (defined as stroke onset to access puncture).
Exclusion Criteria
- Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis.
Data sourced from ClinicalTrials.gov (NCT03364023). 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.