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

Medtronic

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Device: Neurothrombectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT05005962

MDT20026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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), M1 and 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 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

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 for patients with ≤6 hours of stroke onset.
   • ≥10 and ≤30 for patients with >6 hours of stroke onset.

Exclusion criteria

1. 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
2. Patients meeting the contraindication as mentioned in the IFU of devices.
3. Significant mass effect with midline shift

Trial design

200 participants in 1 patient group

Acute ischemic patients suffering with stroke

Description:

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.

Treatment:

Device: Neurothrombectomy