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

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Neurothrombectomy

• Registration Number: NCT05005962
• Lead Sponsor: Medtronic Neurovascular Clinical Affairs

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-16
• Study Start: 2021-08-30
• Primary Completion: 2024-01-31
• Status Verified: 2024-05
• Study Completion: 2024-05-21
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• 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), 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute ischemic patients suffering with stroke	Neurothrombectomy	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.

Primary Outcome Measures

Name	Time	Method
Efficacy Evaluation	Day 7/Discharge after the procedure & 3 month after the procedure	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
Safety Evaluation	from index procedure till 3 month after the procedure performed	Incidence of Neurological Events of Interest, All-cause mortality, Procedure-related AEs, Device-related AEs, and all SAEs
Performance Evaluation	During the Procedure	Time to revascularization and revascularization assessment at the end of the procedure using mTICI score

Secondary Outcome Measures

Name	Time	Method
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	1. Post-acute discharge disposition: discharge to home or any other facility; 2. Subject disposition at study exit; 3. Cost effectiveness: Evaluation of cost effectiveness of Solitaire and/or React Aspiration catheters family of devices will be performed without a statistical test. Therefore, there is no hypothesis test for this ancillary objective. Cost effectiveness will be calculated using a credible model with inputs from the PRAAN study wherever possible (e.g., age, mortality, quality of life). When direct input from the study is not possible, inputs will be derived from prior clinical evidence, from localized outcomes research (within region of from comparable region), or from expert advisory board input. A separate document will outline the plan for evaluating the cost-effectiveness component. Cost effectiveness will be expressed as incremental cost in local currency per quality adjusted life year gained (QALY).

Trial Locations

Locations (14)

Artemis Hospital; 🇮🇳 Gurgaon, Haryana, India

Sir Gangaram Hospital; 🇮🇳 New Delhi, India

HN Reliance; 🇮🇳 Mumbai, Maharashtra, India

CMC Ludhiana; 🇮🇳 Ludhiāna, Punjab, India

Sterling Hospital; 🇮🇳 Ahmadabad, Gujarat, India

Kovai Medical Center & Hospital; 🇮🇳 Coimbatore, Tamil Nadu, India

Medanta; 🇮🇳 Gurgaon, Haryana, India

NIMHANS; 🇮🇳 Bengaluru, Karnataka, India

Narayana Hrudayalaya; 🇮🇳 Bengaluru, Karnataka, India

Yashoda Hospital; 🇮🇳 Secunderabad, Hyderabad, India

Sree Chitra Tirunal Institute for Medical Sciences & Technology; 🇮🇳 Thiruvananthapuram, Kerala, India

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

SRMC; 🇮🇳 Chennai, Tamil Nadu, India

Breach Candy Hospital; 🇮🇳 Mumbai, Maharashtra, India