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Completed

NCT Number: NCT05005962

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sterling Hospital, Ahmedabad, Gujarat, India

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Performance Evaluation

    Time frame: During the Procedure

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

  2. Efficacy Evaluation

    Time frame: Day 7/Discharge after the procedure & 3 month after the procedure

    • 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

  3. Safety Evaluation

    Time frame: 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

Secondary outcomes

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

    Time frame: At subject discharge after the procedure and 3 month after the procedure

    • 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).

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Acronym: PRAAN

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2021
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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