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

NCT05005962 | Completed FDA Device

• 1 other identifier: MDT20026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 14

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Neurothrombectomy; Revascularization

Outcome Measures

Primary Outcomes (3)

• Performance Evaluation

  Time to revascularization and revascularization assessment at the end of the procedure using mTICI score

  During the Procedure

• Efficacy Evaluation

  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

  Day 7/Discharge after the procedure & 3 month after the procedure

• Safety Evaluation

  Incidence of Neurological Events of Interest, All-cause mortality, Procedure-related AEs, Device-related AEs, and all SAEs

  from index procedure till 3 month after the procedure performed

Secondary Outcomes (1)

• Health Economic analysis of neurothrombectomy procedure in the treatment of patients suffering with ACUTE ISCHEMIC STROKE

  At subject discharge after the procedure and 3 month after the procedure

Study Arms (1)

Acute ischemic patients suffering with stroke

Acute ischemic patients treated with commercially available neurothrombectomy devices in India. The device can be either a stent retriever or aspiration catheter to treat the stroke as per the labeling indications of the products.

Device: Neurothrombectomy

Interventions

Neurothrombectomy DEVICE

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.

Acute ischemic patients suffering with stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 200 subjects from 15 sites in India

You may qualify if:

• Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements
• Subject is 18 years of age or older
• 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), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries
• Subject has been or will be treated with a Medtronic market-released neuro thrombectomy device as the initial device used to remove the thrombus
• Subject is willing to participate in a 90-day follow-up visit
• Treatment within 24 hours of last known well. For subjects with stroke onset \>6 hours:
• ASPECTS score \>5 (per DW-MRI) or \>6 (per NCCT)
• NCCT Core Infarct \< 70 ml or MRI DWI with \< 70 ml core volume or CTP Ratio of volume of ischemic tissue (penumbra) to infarction of ≥1.8 and an absolute volume of potentially reversible ischemia of ≥15ml
• Pre-Stroke Modified Rankin Scale (mRS) score ≤1 (immediately) prior to stroke onset
• Pre-treatment National Institutes of Health Stroke Scale (NIHSS)
• ≥6 and ≤30 for patients with ≤6 hours of stroke onset.
• ≥10 and ≤30 for patients with \>6 hours of stroke onset.

You may not qualify if:

• Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis
• Patients meeting the contraindication as mentioned in the IFU of devices.
• Significant mass effect with midline shift

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (14)

Sterling Hospital

Ahmedabad, Gujarat, India

Location

Artemis Hospital

Gurgaon, Haryana, 122001, India

Location

Medanta

Gurgaon, Haryana, India

Location

Yashoda Hospital

Secunderabad, Hyderabad, India

Location

Narayana Hrudayalaya

Bengaluru, Karnataka, 560099, India

Location

NIMHANS

Bengaluru, Karnataka, India

Location

Sree Chitra Tirunal Institute for Medical Sciences & Technology

Thiruvananthapuram, Kerala, 695011, India

Location

Breach Candy Hospital

Mumbai, Maharashtra, India

Location

HN Reliance

Mumbai, Maharashtra, India

Location

CMC Ludhiana

Ludhiana, Punjab, 141008, India

Location

SRMC

Chennai, Tamil Nadu, India

Location

Kovai Medical Center & Hospital

Coimbatore, Tamil Nadu, 641014, India

Location

Rabindranath Tagore International Institute of Cardiac Sciences

Kolkata, West Bengal, 700099, India

Location

Sir Gangaram Hospital

New Delhi, India

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: August 16, 2021
• Study Start: August 30, 2021
• Primary Completion: January 31, 2024
• Study Completion: May 21, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (14)