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NCT07699003

Endovascular Treatment of Chronic Intracranial Artery Occlusion

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

Comparison of the efficacy and safety of endovascular treatment versus medical treatment in patients with chronic intracranial artery occlusion.

Official title: Endovascular Treatment of Chronic Intracranial Artery Occlusion: A Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

382

Start Date

2026-08-01

Completion Date

2030-08-01

Last Updated

2026-07-13

Healthy Volunteers

Conditions

Chronic Intracranial Artery Occlusion

Interventions

PROCEDURE

Endovascular treatment

Endovascular recanalization therapy for chronic atherosclerotic intracranial artery occlusion, including balloon angioplasty and/or stent implantation (e.g., self-expanding or drug-eluting stents) targeting the occluded unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery. The procedure is performed under local or general anesthesia via femoral or radial arterial access, with peri-procedural dual antiplatelet therapy (e.g., aspirin plus clopidogrel) management according to standard institutional protocols.

DRUG

Standard pharmacological treatment

Standard pharmacological treatment: dual antiplatelet (aspirin 100 mg + clopidogrel 75 mg daily) for first 90 days, then single antiplatelet; high-intensity statin (atorvastatin 40-80 mg or rosuvastatin 20-40 mg daily) targeting LDL-C \<1.8 mmol/L; strict BP control (\<140/90 mmHg, or \<130/80 mmHg in diabetics) and glycemic control (HbA1c \<7.0%); uniformly applied across centers with pill-count adherence monitoring.

Inclusion Criteria: 1. Age ≥18 years 2. Occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery, as confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA) 3. Modified Rankin Scale (mRS) score of 0-2 4. Presence of symptoms related to the occluded vessel, as determined by the physician, with the most recent symptom onset occurring more than 4 weeks and within 6 months prior to enrolment 5. The subject or their legally authorised representative has provided written informed consent for the study Exclusion Criteria: 1. Evidence of hemorrhage on CT or MRI 2. Large hemispheric infarction involving \>50% of the middle cerebral artery territory on CT or MRI 3. Severe pre-stroke disability (modified Rankin Scale score ≥2) or life expectancy \<12 months 4. Major comorbidities that may interfere with outcome assessment and follow-up (e.g., severe heart failure, renal failure, etc.) 5. Uncontrolled seizure at the time of stroke onset 6. Baseline platelet count \<50,000/μL 7. Severe, persistent hypertension that remains uncontrolled despite active management (systolic blood pressure \>220 mmHg or diastolic blood pressure \>120 mmHg) 8. Known inherited or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an international normalized ratio (INR) \>3 9. Suspected septic emboli or suspected bacterial endocarditis 10. Known allergy to iodine, heparin, or anaesthetics, or other definite contraindications to endovascular procedures 11. Pregnant women 12. Other severe, progressive, or terminal diseases (as judged by the investigator), or life expectancy \<24 months 13. Prior attempted endovascular recanalization therapy before randomization 14. Current participation in other studies involving investigational drugs or devices 15. Evidence of intracranial tumour on CT or MRI (except meningioma) 16. Excessive tortuosity of cervical vessels on CTA/MRA that may preclude endovascular therapy