ORANGE: Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05024292

Collaborator

Shanghai 10th People's Hospital (Other), Jinshan Branch of Shanghai Sixth People's Hospital (Other), Shanghai Fifth People's Hospital (Other), The First people's Hospital of Kunshan (Other), Zhejiang Huzhou Central Hospital (Other)

1,000

Enrollment

Location

Anticipated Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For patients with acute ischemic stroke (AIS) with anterior circulation proximal large vessel occlusion (LVO), mechanical thrombectomy (MT) reduces disability in patients when it is performed within 6 h of the time the patients with a stroke were last known to be healthy and up to 24 h after stroke onset in patients selected using brain perfusion imaging. For patients with acute ischemic stroke (AIS) with posterior circulation large vessel occlusion, MT could be benefit the patients when performed within 24 hours since onset. This is a multicenter registration study of the AIS-LVO treated with endovascular intervention under the guideline. This study will record the patients' demographic and clinical data, image data, procedure of neurointervention and outcomes in 3 months. Samples of thrombus and serum will be collected and stored for later analysis.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Oriental Research Alliance of Acute Ischemic Stroke Given Endovascular Treatment:A Multicenter Registry Study

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Anterior circulation cerebral infarction
Posterior circulation cerebral infarction

Outcome Measures

Primary Outcome Measures

Modified rankin scale (mRS) at 3 month following [3 month]
mRS 0-2 is defined as good outcome, mRS 3-6 is defined as bad outcome

Secondary Outcome Measures

mRS at 3 month following [3 month]
mRS 0-1 is defined as excellent outcome, mRS 3-6 is defined as non excellent outcome
Mortality following 1 month [1 month]
Mortality of 1 month after stoke onset
Symptomatic intracerebral hemorrhage (sICH) after procedure [period in hospital]
Symptomatic intracerebral hemorrhage

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 - 95.
Clinical signs consistent with acute ischemic stroke.
Prestroke Modified Rankin Score ≤ 2
Consent obtained within 24 hours from last known well.
Thrombolysis in Cerebral Infarction (TICI) 0-1 flow in The M1 or M2 segment of the middle cerebral artery (MCA), A1 or A2 segment of the anterior cerebral artery (ACA), or carotid terminus confirmed by CT or MR angiography; or the vertebral artery, basilar artery, posterior cerebral artery.
For patients with anterior LVO within 6 to 16 hours of last known normal, the imaging criteria to meet: ischemic core less than 70 ml,mismatch ratio of 1.8 or more, and a penumbra of 15 ml or more. For patients with anterior LVO within 6 to 24 hours of last known normal, following criteria: age ≥80 years，NIHSS≥10，infarct volume of less than 21 ml；age ≤80 years，NIHSS≥10，infarct volume of less than 31 ml；age ≤80 years，NIHSS≥20，infarct volume of less than 51 ml.

For patients with posterior LVO, time of onset to admission is within 24 hours.

Subject is willing to conduct protocol-required follow-up visits.
Subject or subject's legally authorized representative has signed and dated an Informed consent Form.

Exclusion Criteria:

Female who is pregnant.
Serious sensitivity to radiographic contrast agents.
Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation.
Warfarin therapy with international normalized ratio(INR) greater than 1.7.
Low molecular Weight Heparins, Heparin, Factor Xa inhibitors or direct thrombin inhibitors as full dose within the last 48 hours.
Baseline lab values: glucose <50 mg/dL or > 400 mg/dL, platelets < 100,000
Life expectancy of less than 90 days.