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RecruitingNCT06009315AURORAUpdated Aug 1, 2024

Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)

An observational study in Acute Ischemic Stroke, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Beijing Tiantan Hospital · Observational

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
949
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Stroke is the leading cause of disability-adjusted life years (DALYs) in China, imposing a heavy burden on society and families. Endovascular therapy (EVT) has opened the 2.0 era of acute ischemic stroke (AIS) treatment, but still up to 1/3 of patients have poor neurological prognosis. The results of several studies at home and abroad and by our team indicate that anesthesia method and perioperative management are one of the key factors affecting the neurological prognosis of EVT treatment in AIS patients. Based on machine learning big data analysis methods, a prognostic model for EVT treatment of AIS patients can be established to guide individualized treatment decisions. Current prediction models only include patients' baseline variables, and lack the inclusion of intraoperative (anesthesia management and interventional process) and postoperative (intensive monitoring treatment) variables, which limits the clinical application of prediction tools. We will establish a large prospective cohort database including preoperative, intraoperative, and postoperative variables, integrate heterogeneous information from multiple sources based on artificial intelligence machine learning algorithms, and build prognostic prediction models with better clinical applicability and calibration, with the aim of optimizing perioperative management of endovascular therapy, guiding individualized clinical decision-making, and improving patients' clinical prognosis.

02

Conditions studied

  • Acute Ischemic Stroke

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Keywords

  • Acute ischemic stroke,
  • Anesthesia
  • Predictive Model
  • Endovascular therapy
  • Deep learning
03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's planned enrollment of 949 is above the median of 300 across 787 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 481 studies on the registry; 287 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute ischemic stroke caused by large undergoing endovascular therapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years;
  • NIHSS score ≥4;
  • Image-confirmed (CTA/MRA/DSA) intracranial large artery occlusion;
  • ASPECT (anterior circulation) or PC-ASPECT (posterior circulation) score ≥3;
  • Endovascular treatment including arterial thrombolysis, mechanical thrombolysis, and angioplasty (onset to puncture time is recommended to be less than 8 hours for anterior circulation and less than 12 hours for posterior circulation; those exceeding the time window will be determined by the neurointerventionalist through imaging assessment);
  • Signed informed consent by the patient or legal representative

Exclusion criteria

Exclusion Criteria:

  • Pre-stroke mRS score >2;
  • Intracranial bleeding disorders: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
  • presence of coagulation disorders, history of systemic bleeding, history of thrombocytopenia or neutropenia;
  • Renal insufficiency with elevated blood creatinine (greater than 2 times the upper limit of normal);
  • Presence of severe cardiopulmonary disease that, in the opinion of the investigator, makes participation in this study unsuitable; patients with a life expectancy of less than 3 months or otherwise unable to complete this study;
  • Contraindication to DSA examination, severe contrast allergy or absolute contraindication to iodine contrast; women of childbearing age who have a negative pregnancy test but refuse to use effective contraception, are pregnant or breast feeding;
  • Those who are unable to complete the study due to psychiatric disorders, cognitive or mood disorders;
  • Other patients who, in the opinion of the investigator, are not suitable for enrollment in the study (specify reason).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
949 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Functional independence at 90 days

    modified Rankin Scale of 0-2

    Time frame: 90±7days after treatment

07

Study locations

1 of 1 sites recruiting
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing Municipality 100070, China
    • Ruquan Han, M.D., Ph.D · Contact · ruquan.han@gmail.com · 8610-59976660
    • Ruquan Han, M.D., Ph.D · Principal investigator
    Recruiting
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References and documents

Publications

  • Wang X, Liang F, Wu Y, Jia B, Wang A, Zhang X, Zhang K, Hou X, Jian M, Wang Y, Liu H, Miao Z, Han R. Development and Validation of a Two-step Model to Predict Outcomes After Endovascular Treatment for Patients With Acute Ischemic Stroke. J Neurosurg Anesthesiol. 2025 Jul 1;37(3):305-312. doi: 10.1097/ANA.0000000000001008. Epub 2024 Sep 18. PubMed 39291867 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Dec 2026, 34 months after the start.

Of 386 non-industry observational studies under Ischemic Stroke, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 167. This study's planned 34 months is below that.

Counting every sponsor, half of 431 studies reached it within 51 months; a quarter within 24 and three quarters within 115.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2023
First posted
Aug 24, 2023
StartActual
Feb 23, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Aug 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06009315
Responsible party
Ruquan Han (Professor & Director, Beijing Tiantan Hospital) — Principal investigator
First posted
Aug 24, 2023
Start date
Feb 23, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 1, 2024

Study contacts

Ruquan Han
Contact
ruquan.han@gmail.com
8610-59976660
Fa Liang
Contact
liangfa1001@163.com
8610-59976658

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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