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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

Tracking Information
First Submitted Date October 18, 2017
First Posted Date December 13, 2017
Last Update Posted Date June 1, 2020
Actual Study Start Date November 11, 2017
Actual Primary Completion Date July 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2020)
  • 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.
  • 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
  • Time from symptom onset to recanalization [ Time Frame: The end of the procedure ]
Original Primary Outcome Measures
 (submitted: December 7, 2017)
  • Time from symptom onset to recanalization [ Time Frame: Up to 840 minutes. From the time of symptom onset until the time of the recanalization of the occluded artery, assessed up to 48 hours ]
    Minutes
  • Functional independence at 90 days (modified Rankin Scale of 0-2) [ Time Frame: 90 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.
  • Symptomatic intracerebral hemorrhage within 24 hours after the procedure [ Time Frame: 24 hours within the procedure ended ]
Change History
Current Secondary Outcome Measures
 (submitted: May 28, 2020)
  • Recanalization rate at the end of the procedure [ Time Frame: at the end of the procedure ]
    mTICI score 2b-3
  • Recanalization rate after the first attempt [ Time Frame: At baseline, during the procedure, after the first attempt of endovascular treatment ]
    mTICI score 2b-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
  • 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
  • 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
  • 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.
  • 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.
  • Parenchymal hematoma (PH2) [ Time Frame: 12-36 hours after the procedure ]
    PH2 is defined as hematoma in >30% of infarct area
  • Any intracranial hemorrhage on imaging [ Time Frame: 12-36 hours after the procedure ]
  • All-cause mortality within 90 days [ Time Frame: 90±7 days after the procedure ]
  • Time from onset to arrival [ Time Frame: At baseline, after arrival at the hospital ]
  • Time from arrival to imaging [ Time Frame: At baseline, after taking any brain imaging ]
  • Time from imaging to puncture [ Time Frame: At baseline, during the procedure, after successful groin puncture ]
  • Time from puncture to recanalization [ Time Frame: At baseline, during the procedure, after successful recanalization ]
Original Secondary Outcome Measures
 (submitted: December 7, 2017)
  • Time from symptom onset to arrival [ Time Frame: From the time of symptom onset until the time of arrival at the emergency department, assessed up to 48 hours ]
    Minutes
  • Time from arrival to imaging [ Time Frame: From the time of arrival at the emergency department until the time of brain imaging, assessed up to 12 hours ]
    Minutes
  • Time from imaging to groin puncture [ Time Frame: From the time of brain imaging until the time of successful groin puncture, assessed up to 12 hours ]
    Minutes
  • Time from groin puncture to recanalization [ Time Frame: From the time of successful groin puncture until the time of the recanalization of the occluded artery, assessed up to 4 hours ]
    Minutes
  • Time from arrival to recanalization [ Time Frame: From the time of arrival at the emergency department until the time of the recanalization of the occluded artery, assessed up to 48 hours ]
    Minutes
  • Recanalization rate immediately after the procedure [ Time Frame: Immediately after the procedure ]
    modified thrombolysis in cerebral infarction (mTICI) 2b-3
  • National Institute of Health stroke scale (NIHSS) immediately after the procedure [ Time Frame: Immediately after the procedure ]
    The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
  • National Institute of Health stroke scale (NIHSS) 24 hours after the procedure [ Time Frame: 24 hours after the procedure ]
    The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
  • Recanalization rate 24 hours after the procedure [ Time Frame: 24 hours after the procedure ]
    Recanalization was defined as a thrombolysis in myocardial infarction (TIMI ) score of 2-3.
  • Infarction volume 24 hours after the procedure [ Time Frame: 24 hours after the procedure ]
    ml
  • National Institute of Health stroke scale (NIHSS) 7 days after the procedure [ Time Frame: 7 days after the procedure ]
    The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
  • EQ-5D 90 days after the procedure [ Time Frame: 90 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.
  • Barthel index (BI) 90 days after the procedure [ Time Frame: 90 days after the procedure ]
    The BI has a score of 0-100. A higher score indicates a better outcome.
  • Intracerebral hemorrhage on brain imaging within 24 hours after the procedure [ Time Frame: 24 hours within the procedure ended ]
  • All cause mortality within 90 days after the procedure [ Time Frame: 90 days after enrollment ]
  • Complications related to the procedure [ Time Frame: 24 hours after the procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke
Official Title Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic stroke-a Prospective Multicenter Registry Study
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 90 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with acute ischemic stroke caused by large vessel occlusion and receiving endovascular treatment.
Condition Intracranial Artery Occlusion With Infarction (Disorder)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 28, 2020)
2004
Original Estimated Enrollment
 (submitted: December 7, 2017)
3000
Actual Study Completion Date July 7, 2019
Actual Primary Completion Date July 7, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03370939
Other Study ID Numbers 2016YFC1301501-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Zhongrong Miao, Beijing Tiantan Hospital
Study Sponsor Beijing Tiantan Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Zhongrong Miao, PhD Capital Medical University, Beijing Tiantan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date May 2020