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Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370939
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Zhongrong Miao, Beijing Tiantan Hospital

Brief Summary:
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.

Condition or disease
Intracranial Artery Occlusion With Infarction (Disorder)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2004 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic stroke-a Prospective Multicenter Registry Study
Actual Study Start Date : November 11, 2017
Actual Primary Completion Date : July 7, 2019
Actual Study Completion Date : July 7, 2019



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute ischemic stroke caused by large vessel occlusion and receiving endovascular treatment.
Criteria

Inclusion criteria

  1. Age ≥ 18 years old;
  2. Diagnosis of acute ischemic stroke;
  3. 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);
  4. Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting;
  5. The patient or the patient's legal representative is able and willing to sign the informed consent.

Exclusion criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370939


Locations
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China, Beijing
Beijing Tiantan Hospital
Beijing, Beijing, China, 100010
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Zhongrong Miao, PhD Capital Medical University, Beijing Tiantan Hospital
Additional Information:

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Responsible Party: Zhongrong Miao, Director, Department of interventional neurology, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03370939    
Other Study ID Numbers: 2016YFC1301501-1
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhongrong Miao, Beijing Tiantan Hospital:
ischemic stroke
endovascular treatment
registry
Additional relevant MeSH terms:
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Infarction
Emergencies
Ischemia
Pathologic Processes
Necrosis
Disease Attributes