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Completed

NCT Number: NCT05092139

Endovascular treatmenT for Acute Ischemic Stroke in China (DETECT2-China)

This is a prospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a Chinese population.

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Key information

Conditions

Stroke, Ischemic 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

Hui-Sheng Chen

Shenyang, Liaoning, 110840, China

Who can participate

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

Inclusion criteria

  • Age: ≥ 18;
  • Ischemic stroke confirmed by head CT or MRI;
  • Patients receiving endovascular treatment;
  • First ever stroke or pre-stroke mRS≤2;
  • signed informed consent.

Exclusion criteria

  • Prestroke mRS≥3;
  • Other serious illness that would confound the clinical outcome at 90 days;
  • Unavailable neuroimaging data;
  • Other unsuitable conditions judged by the investigator

Treatment and study plan

Endovascular treatment

Device

all enrolled patients must receive endovascular treatment

Primary outcomes

  1. Proportion of patients with modified Rankin Score 0 to 2

    Time frame: Day 90

    the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

Secondary outcomes

  1. Proportion of patients with modified Rankin Score 0 to 1

    Time frame: Day 90

    the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

  2. Distribution of modified Rankin Score

    Time frame: Day 90

    the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

  3. Changes in National Institute of Health stroke scale (NIHSS)

    Time frame: 24 hours, 48 hours, and 2 weeks

    the minimum and maximum values of NIHSS are 0 and 24, respectively; higher NIHSS mean a worse outcome

  4. Proportion of symptomatic intracranial hemorrhage (sICH)

    Time frame: 48 hours

    sICH was defined as 4 or more increase in NIHSS caused by hemorrhage

  5. Proportion of death

    Time frame: 7 days

    death due to any cause

Other outcomes

  1. neuroimaging associated with clinical outcome

    Time frame: 48 hours

    neuroimaging included brain CT, MRI or digital subtraction angiography

  2. changes in serum biomarkers

    Time frame: 48 hours

    biomarker included Matrix metalloproteinases, proinflammatory cytokines, and etc.

  3. dynamic changes of TCD data associated

    Time frame: 24 hours

    transcranial Doppler (TCD) data including blood velocity and pulse index, which will be collected at some centers

  4. dynamic changes of cortical blood oxygen saturation by near infrared spectroscopy

    Time frame: 24 hours

    The data will be collected at some centers

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

enDovascular trEatmenT for acutE isChemic sTroke in China (DETECT2-China): a Prospective, National, Multi-center, Registry Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 25, 2021
Registry last updated
Mar 18, 2025

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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