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Completed

NCT Number: NCT03364023

Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia

The purpose of this post-market registry is to collect real-world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

National Neuroscience Institute, Singapore

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About this study

This is a prospective, multi-center, non-randomized, observational registry designed to collect real world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia, including Singapore, Thailand and Vietnam. The primary objective of this registry is to assess clinical outcomes associated with the use of these devices in patients experiencing AIS due to large intracranial vessel occlusion within 8 hours of symptom onset. This registry may enroll up to 500 patients.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Who can participate

Healthy volunteers accepted: No

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 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 neurothrombectomy device as the initial device used to remove the thrombus.
  • Subject is willing to participate in a 90-day follow-up visit.
  • Treatment within 8 hours of stroke symptom onset (defined as stroke onset to access puncture).

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.

Treatment and study plan

Neurothrombectomy

Device

Medtronic Market-Released Neurothrombectomy Device

Primary outcomes

  1. Modified Rankin Scale (mRS) at 90 Days

    Time frame: 90 Days Post Procedure

    mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.

    0 No symptoms at all

    • No significant disability despite symptoms; able to carry out all usual duties and activities
    • Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • Moderate disability; requiring some help, but able to walk without assistance
    • Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • Dead

Secondary outcomes

  1. Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure

    Time frame: 24 hrs ± 8 hrs post procedure

    Number of participants with symptomatic Intracranial hemorrhage (sICH) is defined as >/= 4 points worsening from baseline on the National Institutes of Health Stroke Scale (NIHSS) associated with an image finding of intra-cranial hemorrhage (i.e., intracerebral or intraventricular) at 24 +/- 8 hrs post procedure.

    The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.

  2. All-Cause Mortality Through 90 Days Post Procedure

    Time frame: 90 Days Post Procedure

    Death through 90 days post procedure classified as neurological or non-neurological, with event leading to death.

  3. Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure

    Time frame: 24 hrs ± 8 hrs post procedure

    Emboli in New Territory (ENT) is defined as embolization territories outside of the target downstream territory.

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Official study title

Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia (PROSPR-SEA)

Acronym: PROSPR-SEA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2017
Registry last updated
Aug 19, 2020

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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