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Completed

NCT Number: NCT03370939

Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke

Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The prospective Chinese ANGEL-ACT Registry (Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke) was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, funded by National Key R&D Program of China. A total of 2,000 patients with acute ischemic stroke will undergo endovascular treatment. The hypothesis was that favorable outcomes from clinical trials could be achieved in clinical practice in China.

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Key information

Conditions

Intracranial Artery Occlusion With Infarction (Disorder) 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

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100010, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old;
  • Diagnosis of acute ischemic stroke;
  • Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);
  • Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting;
  • The patient or the patient's legal representative is able and willing to sign the informed consent.

Exclusion criteria

  • Isolated cervical ICA or VA occlusion;
  • No evidence of LVO on DSA.

Treatment and study plan

Primary outcomes

  1. Functional independence at 90 days (modified Rankin Scale of 0-2)

    Time frame: 90±7 days after enrollment

    The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome.

  2. Symptomatic intracranial hemorrhage (sICH) within 12-36 hours after the procedure

    Time frame: 12-36 hours after the procedure

    Heidelberg Bleeding Classification): new intracranial hemorrhage detected by brain imaging associated with ≥4 points total National Institutes of Health Stroke Scale (NIHSS), ≥2 points in one NIHSS category, leading to intubation/ hemicraniectomy/ EVD placement or other major medical/surgical intervention, or absence of alternative explanation for deterioration

  3. Time from symptom onset to recanalization

    Time frame: The end of the procedure

Secondary outcomes

  1. Recanalization rate at the end of the procedure

    Time frame: at the end of the procedure

    mTICI score 2b-3

  2. Recanalization rate after the first attempt

    Time frame: At baseline, during the procedure, after the first attempt of endovascular treatment

    mTICI score 2b-3

  3. Changes in NIHSS score immediately after the procedure

    Time frame: within 2 hours after the procedure

    difference between NIHSS score immediately after the procedure and baseline

  4. Changes in NIHSS score 24 hours after the procedure

    Time frame: 24 hours after the procedure

    difference between NIHSS score 24 hours after the procedure and baseline

  5. Changes in NIHSS score 7 days after the procedure or at discharge

    Time frame: 7 days after the procedure or discharge

    difference between NIHSS score 7 days after the procedure or discharge and baseline

  6. EQ-5D 90 days after the procedure

    Time frame: 90±7 days after the procedure

    EQ-5D is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).A higher score indicates a better outcome.

  7. Barthel index (BI) 90 days after the procedure

    Time frame: 90±7 days after the procedure

    The BI has a score of 0-100. A higher score indicates a better outcome.

  8. Parenchymal hematoma (PH2)

    Time frame: 12-36 hours after the procedure

    PH2 is defined as hematoma in >30% of infarct area

  9. Any intracranial hemorrhage on imaging

    Time frame: 12-36 hours after the procedure

  10. All-cause mortality within 90 days

    Time frame: 90±7 days after the procedure

  11. Time from onset to arrival

    Time frame: At baseline, after arrival at the hospital

  12. Time from arrival to imaging

    Time frame: At baseline, after taking any brain imaging

  13. Time from imaging to puncture

    Time frame: At baseline, during the procedure, after successful groin puncture

  14. Time from puncture to recanalization

    Time frame: At baseline, during the procedure, after successful recanalization

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic stroke-a Prospective Multicenter Registry Study

Acronym: ANGEL-ACT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2017
Registry last updated
Jun 1, 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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