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Endovascular Treatment for Acute Basilar Artery Occlusion

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: NCT04751708
Recruitment Status : Completed
First Posted : February 12, 2021
Last Update Posted : September 15, 2022
Sponsor:
Information provided by (Responsible Party):
Wei Hu, The First Affiliated Hospital of University of Science and Technology of China

Tracking Information
First Submitted Date  ICMJE February 9, 2021
First Posted Date  ICMJE February 12, 2021
Last Update Posted Date September 15, 2022
Actual Study Start Date  ICMJE February 21, 2021
Actual Primary Completion Date January 3, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
a modified Rankin Score of 0-3 [ Time Frame: 90 (± 14 days) after procedure ]
Favourable outcome at day 90 (± 14 days)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2021)
  • a modified Rankin Score of 0-2 [ Time Frame: 90 (± 14 days) after procedure ]
    Excellent outcome
  • Modified Rankin Score [ Time Frame: 90 (± 14 days) after procedure ]
    The mRS is an ordinal hierarchical scale ranging from 0 to 5, with higher scores indicating more severe disability.
  • NIHSS score [ Time Frame: 24 hours after procedure ]
    The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
  • NIHSS score [ Time Frame: 5-7 days after procedure ]
    The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
  • mortality [ Time Frame: 90 (± 14 days) after procedure ]
    (Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%
  • symptomatic intracerebral hemorrhage (ICH) [ Time Frame: within 72 hours after procedure ]
    SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
  • a modified Rankin Score of 0-2 [ Time Frame: 90 (± 14 days) after procedure ]
    Excellent outcome
  • Modified Rankin Score [ Time Frame: 90 (± 14 days) after procedure ]
    Change of mRS score (shift analysis)
  • NIHSS score [ Time Frame: 24 hours after procedure ]
  • NIHSS score [ Time Frame: 5-7 days after procedure ]
  • mortality [ Time Frame: 90 (± 14 days) after procedure ]
  • symptomatic intracerebral hemorrhage (ICH) [ Time Frame: within 72 hours after procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endovascular Treatment for Acute Basilar Artery Occlusion
Official Title  ICMJE Endovascular Treatment for Acute Basilar Artery Occlusion - a Multicenter Randomized Clinical Trial
Brief Summary

Rationale: Recently, two prospective multicenter RCT reported a potential beneficial effect of endovascular thrombectomy (EVT) in patients with an acute symptomatic basilar artery occlusion (BAO). However, the high rate of crossover in BEST study and the long-term of recruitment in BASICS study influenced the validity of the results. Besides, a recently prospective clinical registry with large sample size (BASILAR) showed a significantly beneficial effect of EVT in BAO patients.

Objective: To assess the effect of EVT in addition to best medical management (BMM) compared to BMM alone, in patients with BAO, caused by a CTA/MRA confirmed occlusion of the basilar artery on functional and safety outcome.

Study design: This is a parallel group, randomized clinical trial of EVT with BMM versus BMM. The trial has observer blind assessment of the primary outcome and of neuro-imaging at baseline and follow up.

Study population: Patients with acute ischemic stroke and a confirmed basilar artery occlusion by CTA/MRA.

Main study parameters/outcomes: The primary effect parameter will be favourable outcome at day 90 defined as a modified Rankin Score (mRS) of 0-3. The estimate will be adjusted for the known prognostic variables age, pre-stroke mRS, time from onset to randomization, stroke severity (NIHSS) and collaterals and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Basilar Artery Occlusion
  • Acute Cerebrovascular Accident
  • Stroke Due to Basilar Artery Occlusion
Intervention  ICMJE
  • Procedure: endovascular treatment
    For patients randomized to endovascular treatment arm, EVT has to be initiated within 12 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. The endovascular procedures allowed by the steering committee include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or any combination of above procedures. We recommend applying ADAPT as the first choice of treatment. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.
  • Other: best medical management
    best medical management
Study Arms  ICMJE
  • Active Comparator: best medical management
    Unless contra-indicated patients are treated with a standard full dose of open-label IV rt-PA (0.9mg/kg; 90mg maximum). IVT has to be initiated within 4.5 hours of estimated time of basilar artery occlusion. For the patients in whom the rtPA is contraindicated, the standard medical treatment follows the current guidelines for the early management of patients with acute ischemic stroke from the American Heart Association/American Stroke Association.
    Intervention: Other: best medical management
  • Experimental: endovascular treatment+ best medical management
    Device: endovascular treatment For patients randomized to endovascular treatment arm, EVT has to be initiated within 12 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. The endovascular procedures allowed by the steering committee include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or any combination of above procedures. We recommend applying ADAPT as the first choice of treatment. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.
    Intervention: Procedure: endovascular treatment
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2022)
340
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2021)
204
Actual Study Completion Date  ICMJE April 3, 2022
Actual Primary Completion Date January 3, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Symptoms and signs compatible with ischemia in the basilar artery territory;
  2. Basilar artery occlusion confirmed by CTA/MRA/DSA;
  3. Age of 18 years or older;
  4. Time from stroke onset to randomization within 12 hours of estimated time of basilar artery occlusion (defined as the sudden onset of stroke symptoms consistent with acute occlusion of the basilar artery (e.g. not considering any previous minor prodromal symptoms) as adjudicated by two local experienced neurologists). If symptoms of sudden deterioration are not witnessed (e.g. wake-up or unwitnessed strokes) the time that the patient was last known to be without any major neurological deficits (such as moderate or severe weakness, stupor, coma) will be used as the time of stroke onset.
  5. Written informed consent;
  6. National Institutes of Health Stroke Scale (NIHSS) score ≥10 at the time of neuroimaging Exclusion criteria

1. Pre-existing dependency with mRS ≥3 for patients<80 years; premorbid mRS≥1 for patients≥80 years; 2. bilateral mydriasis; 3. Pregnancy; if a woman is of childbearing potential a urine or serum beta HCG test is positive; 4. Severe contrast allergy or absolute contraindication to iodinated contrast; 5. Participation in other clinical trials; 6. Systolic pressure >185 mmHg or diastolic pressure >110 mmHg, and cannot be controlled by antihypertensive drugs; 7. Known genetic or acquired bleeding constitution, lack of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7; 8. Blood glucose < 2.7 or >22.2 mmol / L; platelet count < 50×109 / L, or hematocrit < 25%; 9. Life expectancy < 1 year; 10. Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.); 11. Acute ischemic cerebral infarction within 48 hours after major surgery (patients can be enrolled if more than 48 hours); 12. Premorbid cerebrovascular inflammation; 13. Premorbid nervous system disease or mental disorders hindering the assessment of the disease; Imaging exclusion criteria

  1. CT/MR shows intracranial hemorrhage (patients with microbleeds on MR can be included if lesion diameter ≤5mm);
  2. CTA/MRA/DSA shows the artery is seriously tortuous, variability or dissection, and thrombectomy device cannot reach the target vessel;
  3. PC-ASPECTS on CT/CTA-Source Images/MRI-DWI <6 for patients<80 years (<8 for patients ≥80 years);
  4. CT or MR shows the cerebellar infarction with obvious space occupying effect and obvious compression of the fourth ventricle;
  5. Complete bilateral thalami or bilateral brainstem infarction confirmed by CT/MR;
  6. Occlusion of both anterior and posterior circulation confirmed by CTA/MRA/DSA;
  7. Intracranial tumors (except small meningiomas).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04751708
Other Study ID Numbers  ICMJE Attention
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Wei Hu, The First Affiliated Hospital of University of Science and Technology of China
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The First Affiliated Hospital of University of Science and Technology of China
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital of University of Science and Technology of China
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP