NCT03364023

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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 ischemic stroke (AIS) patients from countries in South East Asia, including Singapore, Thailand and Vietnam. The primary objective of this registry is to assess clinical outcomes associated with the use of these devices in patients experiencing AIS due to large intracranial vessel occlusion within 8 hours of symptom onset. This registry may enroll up to 500 patients. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DEVICE	Neurothrombectomy	Medtronic Market-Released Neurothrombectomy Device

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-07-02
• Completion: 2019-07-02
• First posted: 2017-12-06
• Last updated: 2020-08-19
• Results posted: 2020-08-19

Locations

10 sites across 3 countries: Singapore, Thailand, Vietnam

Regulatory

• FDA-regulated device study