NCT05005962

Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

PRAAN is a post-market registry designed to collect real-world data associated with the use of Medtronic market release neurothrombectomy devices in acute ischemic stroke (AIS) patients from India.

Detailed description

The objective of this registry is to access clinical outcomes associated with the use of these device in patients experiencing the AIS due to large intracranial vessel occlusion within 8 hours of last known well. Real-world evidence per Standard-of-care (SOC) will be generated using Medtronic neurothrombectomy devices approved in India, using on-label indications for use in this post-market clinical follow-up registry.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Neurothrombectomy	Neurothrombectomy device will be used to treat patients experiencing the AIS due to large intracranial vessel occlusion within 8 hours of last known well to collect real-world data and to access clinical outcomes associated with the use of these devices.

Timeline

• Start date: 2021-08-30
• Primary completion: 2024-01-31
• Completion: 2024-05-21
• First posted: 2021-08-16
• Last updated: 2024-05-30

Locations

14 sites across 1 country: India

Regulatory

• FDA-regulated device study