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NCT Number: NCT06290076

A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy

To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Endovascular Thrombectomy Ischemic Stroke Malignant Cerebral Edema Nervous System Diseases Stroke Symptomatic Intracranial Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

About this study

Acute ischemic stroke (AIS) accounts for about 80% of all strokes. The focus of AIS treatment is to restore reperfusion of ischemic territory as soon as possible, promote neurological recovery, reduce disability rate and improve long-term survival rate. In recent years, a series of randomized clinical trials have proved that endovascular thrombectomy (EVT) is safe and effective in the treatment of anterior circulation AIS. EVT has been recommend as the first-line treatment for anterior circulation large vessel occlusion (LVO) stroke by guidelines.

Symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE) are the two most common severe neurological complications, leading to brain tissue hypoxia and neurological dysfunction. Currently, there is a lack of prediction system to identify patients at high risk for severe complications, who can most likely benefit from adjuvant treatment after thrombectomy to improve patient functional independence and survival rate.

Who can participate

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

Inclusion criteria

  • Symptoms and signs compatible with ischemia in the anterior circulation
  • Internal carotid artery occlusion or middle cerebral artery M1 and M2 segment occlusion confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)
  • Premorbid mRS ≤1;
  • National Institutes of Health Stroke Score (NIHSS) ≥6 at admission;
  • Onset to puncture time ≤24h;
  • Treated with thrombectomy resulting in mTICI score ≥2b at end of the procedure.

Exclusion criteria

  • Intracranial hemorrhage, aneurysm, and arteriovenous malformation before endovascular thrombectomy;
  • Perioperative complications, including dissection and arterial perforation;
  • Anticipated life expectancy <3 months;
  • Critical baseline clinical, laboratory and imaging data are missing;
  • Lack of follow-up results within 72 hours and 90 days after thrombectomy;
  • Pregnant or lactating women;
  • Severe systemic diseases (e.g. advanced cancer), potentially interfering with prognosis;
  • Allergy to contrast media and nitinol;
  • Concurrent participation in a study that would interfere with the establishment of predictive models;
  • Unable to complete the assessment due to mental disorders cognitive or emotional disorders before onset.

Treatment and study plan

Primary outcomes

  1. Rate of severe complications

    Time frame: Within 72 hours after thrombectomy

    Severe complications include symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE). SICH was defined as any intracranial hemorrhage on the non-contrast CT scan accompanied with clinical deterioration, as defined by a increase of ≥4 points in the NIHSS score, or that led to death and that was identified as the predominant cause of the neurologic deterioration.

    MCE was defined as a malignant state in which neurological function deteriorates progressively due to brain edema after endovascular thrombectomy, causing disturbance of consciousness, anisocoria, and midline shift of 5 mm or more on imaging, leading to brain herniation or death. Midline shift was obtained by measuring the point of maximum deviation perpendicular to the line connecting the anterior and posterior attachment points of the falx cerebri.

Secondary outcomes

  1. Rate of mRS score of 3-6

    Time frame: 90 days (±7 days) after thrombectomy

    The mRS score range from 0 (no disability) to 6 (death)

  2. Rate of mRS score of 5-6

    Time frame: 90 days (±7 days) after thrombectomy

    The mRS score range from 0 (no disability) to 6 (death)

  3. Rate of symptomatic intracranial hemorrhage

    Time frame: Within 72 hours after thrombectomy

    SICH was defined as any intracranial hemorrhage on the non-contrast CT scan accompanied with clinical deterioration, as defined by a increase of ≥4 points in the NIHSS score, or that led to death and that was identified as the predominant cause of the neurologic deterioration.

  4. Rate of malignant cerebral edema

    Time frame: Within 72 hours after thrombectomy

    MCE was defined as a malignant state in which neurological function deteriorates progressively due to brain edema after endovascular thrombectomy, causing disturbance of consciousness, anisocoria, and midline shift of 5 mm or more on imaging, leading to brain herniation or death. Midline shift was obtained by measuring the point of maximum deviation perpendicular to the line connecting the anterior and posterior attachment points of the falx cerebri.

  5. Change of NIHSS score

    Time frame: 24-72 hours after thrombectomy versus admission

    The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)

  6. Rate of modified Rankin Scale (mRS) score of 0-2

    Time frame: 90 days (±7 days) after thrombectomy

    The mRS score range from 0 (no disability) to 6 (death)

  7. All-cause mortality

    Time frame: 90 days (±7 days) after thrombectomy

    Death defined as a mRS score of 6

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy: a Retrospective, Multicenter, Observational Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2024
Registry last updated
Mar 4, 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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