Prospective Registry for Assessment of Acute Ischemic Stroke Patients

Phase 4

Completed

• Conditions: Health Condition 1: I633- Cerebral infarction due to thrombosis of cerebral arteries

• Registration Number: CTRI/2021/07/034719
• Lead Sponsor: India Medtronic Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-01-31
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. Subject/subject’s legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements

2.Subject is 18 years of age or older

3. 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), M1and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries

4.Subject has been or will be treated with a Medtronic market ?released neuro thrombectomy

device as the initial device used to remove the thrombus

5.Subject is willing to participate in a 90 ?day follow ?up visit

6.Treatment within 8 hours of last known well

7.Pre-Stroke Modified Rankin Scale (mRS) score =1 (immediately) prior to stroke onset

8.Pre-treatment National Institutes of Health Stroke Scale (NIHSS) = 6 and = 30

Exclusion Criteria

Patient must not meet any of the following general exclusion criteria:

1. Concurrent participation in another mechanical neuro thrombectomy device trial or any other

clinical trial with an active treatment arm or where the study procedure or treatment might

confound the study analysis

2.Patients meeting the contraindication as mention in the IFU of devices

3.Patients identified with active COVID-19 infection at the time of enrollment

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mTICI score <br/ ><br>NIHSS <br/ ><br>mRS scoreTimepoint: Enrolment, Discharge and 90 days

Secondary Outcome Measures

Name	Time	Method
Cost effectiveness, <br/ ><br>mRS, NIHSS <br/ ><br>Timepoint: Discharge and 90 day follow up <br/ ><br>