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Endovascular treatment versus Aggressive medical management for SymptomaTic Chronic intErnal carotid aRtery occlusioN (EASTERN): a multicenter, prospective, open-label, blinded endpoint assessment, randomized controlled trial

Endovascular treatment versus Aggressive medical management for SymptomaTic Chronic intErnal carotid aRtery occlusioN (EASTERN): a multicenter, prospective, open-label, blinded endpoint assessment, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105032
Enrollment
Unknown
Registered
2025-06-27
Start date
2025-07-17
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Internal Carotid Artery Occlusion

Interventions

Test group:The test group was treated with endovascular therapy plus active drug therapy.
Control group:The control group was actively treated with medication

Sponsors

Guangdong Second Provincial General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old; 2. Symptomatic onset within 12 months prior to randomization, manifested as transient ischemic attack (TIA), non-disabling or mild-to-moderate stroke in the area of responsible vascular blood supply (subject's modified Rankin scale (mRS) score at randomization =1 time) or the presence of abnormal perfusion in the responsible vascular blood supply area confirmed by CTP (MTT>4s, rCBF<0.95); 6. The patient or legal representative is able to understand the purpose of the trial, voluntarily participate in and sign a written informed consent form, and is able to accept regular follow-up.

Exclusion criteria

Exclusion criteria: 1. Previous history of cerebral hemorrhage, and/or large cerebral infarction (infarct volume > 70ml or infarct area greater than 1/3 of the middle cerebral artery blood supply area); 2. Known presence of an aneurysm in the ipsilateral intracranial segment of the occluded internal carotid artery; 3. Previous definite myocardial infarction or severe heart failure (NYHA cardiac function class III./IV.); 4. Presence of active bleeding, severe anemia, coagulation dysfunction (presence of at least one of the following laboratory tests: hemoglobin 1.5, PT >1 minute above the upper limit of normal, or heparin-related thrombocytopenia); 5. Gastrointestinal or urinary hemorrhage, head injury or major surgery in the past 1 month; 6. Ipsilateral vascular prior interventions such as stent implantation, balloon dilation, or coil tamponade; 7. Imaging abnormalities with severe vascular flexure or anatomical, extensive or diffuse atherosclerotic disease involving the aortic arch and proximal common carotid artery, etc., which in the opinion of the investigator is expected to be unable to complete the operation; 8. Allergy to any contrast agent or device related to endovascular treatment or other contraindications to cerebral angiography; 9. Severe concomitant diseases with poor prognosis (life expectancy < 2 years); 10. Females known to be pregnant or lactating; 11. Unwilling to accept randomized selection of treatment regimens, unable to understand and cooperate with study procedures or provide informed consent; 12. Participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The incidence of composite endpoint events of stroke or death within 30 days after randomization or ipsilateral ischemic stroke from 30 days to 2 years later.;Endovascular treatment of complications;

Secondary

MeasureTime frame
Incidence of any stroke within 2 years of randomization;Incidence of all disabling strokes within 2 years of randomization;Incidence of all fatal strokes within 2 years of randomization;Incidence of any death within 2 years of randomization;Incidence of any stroke and death within 2 years of randomization;The score of the Modified Rankin Scale;National Institute of Health stroke scale;

Countries

China

Contacts

Public ContactZhixin Huang

Guangdong Second Provincial General Hospital

hzxd6@163.com+86 188 9854 6655

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026