Prospective Registry for Assessment of Acute Ischemic Stroke Patients

Not Applicable

Completed

• Conditions: Cerebral infarction due to thrombosis of cerebral arteries,

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

Brief Summary

The purpose of this registry is to assess clinical outcomes and different factors that may affect these clinical outcomes that are associated with the use of Medtronic market-released neurothrombectomy devices SolitaireTM and/or ReactTM Aspiration catheters family of devices intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion. A postâ€market registry designed to collect real world data associated with the use of Medtronic marketâ€released neurothrombectomy devices in acute ischemic stroke (AIS) patients from India.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-30
• Study Completion: 2024-01-31
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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 marketâ€released neuro thrombectomy device as the initial device used to remove the thrombus 5.Subject is willing to participate in a 90â€day followâ€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	Enrolment, Discharge and 90 days
NIHSS	Enrolment, Discharge and 90 days
mRS score	Enrolment, Discharge and 90 days

Secondary Outcome Measures

Name	Time	Method
Cost effectiveness,	mRS, NIHSS

Trial Locations

Locations (15)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Artemis Hospital; 🇮🇳 Gurgaon, HARYANA, India

Breach Candy Hospital Trust; 🇮🇳 Mumbai, MAHARASHTRA, India

CHRISTIAN MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Ludhiana, PUNJAB, India

Kovai Medical Center & Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Medanta – The Medicity; 🇮🇳 Gurgaon, HARYANA, India

Narayana Hrudayalaya; 🇮🇳 Bangalore, KARNATAKA, India

Rabindranath Tagore International Institute of Cardiac Sciences; 🇮🇳 Kolkata, WEST BENGAL, India

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

Sir H N Reliance Foundation Hospital and Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Scroll for more (5 remaining)

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Shailesh Gaikwad

Principal investigator

9971237573

sgaikwad_63@yahoo.com