Status:

COMPLETED

Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia

Lead Sponsor:

Medtronic Neurovascular Clinical Affairs

Conditions:

Stroke, Acute

Eligibility:

All Genders

Brief 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 count...

Detailed Description

This is a prospective, multi-center, non-randomized, observational registry designed to collect real world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ...

Eligibility Criteria

Inclusion

  • 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

  • 1\. 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.

Key Trial Info

Start Date :

January 1 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 2 2019

Estimated Enrollment :

183 Patients enrolled

Trial Details

Trial ID

NCT03364023

Start Date

January 1 2018

End Date

July 2 2019

Last Update

August 19 2020

Active Locations (10)

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Page 1 of 3 (10 locations)

1

National Neuroscience Institute

Singapore, Singapore

2

National University Hospital

Singapore, Singapore

3

Singapore General Hospital

Singapore, Singapore

4

Prasat Neurology Institute

Bangkok, Thailand