Prospective Registry for Assessment of Acute Ischemic Stroke Patients

Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated with Neurothrombectomy Devices in India - PRAAN

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/07/034719

Enrollment

200

Registered

2021-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Neurothrombectomy: Treatment of patients suffering with acute ischemic stroke due to larger intracranial vessel occlusions will be treated with neuro thrombectomy device which intend to

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
mTICI score NIHSS mRS scoreTimepoint: Enrolment, Discharge and 90 days	—

Secondary

Measure	Time frame
Cost effectiveness, mRS, NIHSS Timepoint: Discharge and 90 day follow up	—

Countries

India

Contacts

Public ContactVinay Rajan

India Medtronic Pvt Ltd

vinay.rajan@medtronic.com00919619332703

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026