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NCT05005962Completed

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

Source: ClinicalTrials.gov · Last updated 30 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
200 (actual)
First submitted
29 Jun 2021
Start date
30 Aug 2021
Primary completion date
31 Jan 2024
Lead sponsor
Medtronic Neurovascular Clinical Affairs
Diseases
Stroke
NCT number
NCT05005962

What you commit to

  • Study type: Observational
  • Participants enrolled: 200
  • From 30 Aug 2021 to the primary completion date, 31 Jan 2024
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sterling Hospital
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AhmedabadIndiaUnknown status
NIMHANS
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BengaluruIndiaUnknown status
Narayana Hrudayalaya
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BengaluruIndiaUnknown status
SRMC
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ChennaiIndiaUnknown status
Kovai Medical Center & Hospital
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CoimbatoreIndiaUnknown status
Artemis hospital
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GurgaonIndiaUnknown status
Medanta
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GurgaonIndiaUnknown status
Rabindranath Tagore International Institute of Cardiac Sciences
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KolkataIndiaUnknown status
CMC Ludhiana
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LudhianaIndiaUnknown status
HN Reliance
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MumbaiIndiaUnknown status
Breach Candy Hospital
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MumbaiIndiaUnknown status
Sir Gangaram Hospital
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New DelhiIndiaUnknown status
Yashoda Hospital
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SecunderabadIndiaUnknown status
Sree Chitra Tirunal Institute for Medical Sciences & Technology
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ThiruvananthapuramIndiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.