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

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Neurothrombectomy

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• India
  • New Delhi, India
    • Sir Gangaram Hospital
  • Gujarat
    • Ahmadabad, Gujarat, India
      • Sterling Hospital
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Artemis Hospital
    • Gurgaon, Haryana, India
      • Medanta
  • Hyderabad
    • Secunderabad, Hyderabad, India
      • Yashoda Hospital
  • Karnataka
    • Bengaluru, Karnataka, India, 560099
      • Narayana Hrudayalaya
    • Bengaluru, Karnataka, India
      • NIMHANS
  • Kerala
    • Thiruvananthapuram, Kerala, India, 695011
      • Sree Chitra Tirunal Institute for Medical Sciences & Technology
  • Maharashtra
    • Mumbai, Maharashtra, India
      • Breach Candy Hospital
    • Mumbai, Maharashtra, India
      • HN Reliance
  • Punjab
    • Ludhiāna, Punjab, India, 141008
      • CMC Ludhiana
  • Tamil Nadu
    • Chennai, Tamil Nadu, India
      • SRMC
    • Coimbatore, Tamil Nadu, India, 641014
      • Kovai Medical Center & Hospital
  • WEST Bengal
    • Kolkata, WEST Bengal, India, 700099
      • Rabindranath Tagore International Institute of Cardiac Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Up to 200 subjects from 15 sites in India

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance Evaluation	Time to revascularization and revascularization assessment at the end of the procedure using mTICI score	During the Procedure
Efficacy Evaluation	NIHSS at day 7 or discharge, whichever comes first; mRS at discharge or day 7; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Economic analysis of neurothrombectomy procedure in the treatment of patients suffering with ACUTE ISCHEMIC STROKE	Post-acute discharge disposition: discharge to home or any other facility; Subject disposition at study exit; 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).	At subject discharge after the procedure and 3 month after the procedure

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): May 21, 2024

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Revascularization; Acute Ischemic Stroke; Neurothrombectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: MDT20026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No