Completed
OBSERVATIONAL
NCT05005962
Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Neurothrombectomy
Type:
DEVICE
Description:
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.
Primary Outcomes
Measure:
Performance Evaluation
TimeFrame:
During the Procedure
Description:
Time to revascularization and revascularization assessment at the end of the procedure using mTICI score
Measure:
Efficacy Evaluation
TimeFrame:
Day 7/Discharge after the procedure & 3 month after the procedure
Description:
1. NIHSS at day 7 or discharge, whichever comes first
2. mRS at discharge or day 7
3. mRS and NIHSS score at 90 days post index stroke procedure
Measure:
Safety Evaluation
TimeFrame:
from index procedure till 3 month after the procedure performed
Description:
Incidence of Neurological Events of Interest, All-cause mortality, Procedure-related AEs, Device-related AEs, and all SAEs
Trial Information
NCT ID
NCT05005962
Status
Completed
Study Type
OBSERVATIONAL
Sponsor
Medtronic Neurovascular Clinical Affairs
Last Updated
December 15, 2025