Endovascular Treatment of Chronic Intracranial Artery Occlusion

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Intracranial Artery Occlusion
• Intervention / Treatment: Procedure: Endovascular treatment; Drug: Standard pharmacological treatment

Detailed Description

This study is a multicenter, outcome-blinded, randomized controlled trial designed to evaluate the safety and efficacy of endovascular therapy combined with standard medical therapy versus standard medical therapy alone in patients with chronic intracranial artery occlusion. A total of 382 patients (191 per group) aged ≥18 years with chronic occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery confirmed by CTA, MRA, or DSA will be enrolled and randomly assigned to the experimental group (endovascular therapy + standard medical therapy) or the control group (standard medical therapy alone). The primary endpoint is stroke or death within 30 days after enrollment, or any ischemic stroke related to the responsible artery occurring from 30 days to 12 months after enrollment. Secondary endpoints include any stroke or death within 30 days after randomization; any stroke within 12 months after the procedure; disabling stroke within 12 months after the procedure; fatal stroke within 12 months after the procedure; any death within 12 months after the procedure; mRS score at 12 months; NIHSS score at 12 months; successful reperfusion rate of endovascular therapy; and procedure-related complications.

• Study Type: Interventional
• Enrollment (Estimated): 382
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Hu, Doctor; Phone Number: +86 13707114863; Email: hubo@mail.hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group; Standard pharmacological treatment	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.
Experimental: Test group; Endovascular treatment combined with standard pharmacological treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke or death within 30 days after enrollment, or any ischemic stroke of the qualifying artery after 30 days through 12 months after enrollment	A stroke is defined as rapid loss of neurological function due to ischaemia or a haemorrhage. CT or MRI scanning is necessary to identify the stroke.	Within 30 days post-enrollment; and 30 days to 12 months post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disabling stroke within 12 months post-procedure	Stroke is diagnosed by an independent outcome committee which is composed with experienced neurologists. CT or MR scans will be collected as adjunct evidence for outcome classification of ischemic or hemorrhagic stroke.	12 months post-procedure
Successful reperfusion rate		End of the procedure
Any stroke within 12 months post-procedure	Stroke is diagnosed by an independent outcome committee which is composed with experienced neurologists. Additional key neuro-images (CT or MR scans) will be collected as adjunct evidence for outcome classification of ischemic or hemorrhagic stroke.	12 months post-procedure
Residual stenosis of target vessel at 12 months	The degree of target artery stenosis based on following-up neurovascular imaging	12 months post-procedure
Fatal stroke within 12 months post-procedure	A cerebrovascular event that directly causes death or leads to irreversible brain damage resulting in imminent death based on CT or MR scans	12 months post-procedure
NIHSS score at 12 months	The National Institutes of Health Stroke Scale (NIHSS) Scores range from a minimum of 0 (normal) to a maximum of 42 (profound impairment). Higher scores indicate a worse outcome, as they correspond to more severe stroke symptoms and poorer long-term prognosis.	12 months post-procedure
mRS score at 12 months	Modified Rankin Scale：1. Total asymptomatic score 0 2, despite symptoms, but no obvious dysfunction, can complete all daily work and life score 1 Mildly disabled, unable to complete all pre-illness activities, but able to take care of daily tasks without assistance score 2 3, moderate disability, need some help, but can walk independently score 3 4, moderate to severe disability, can not walk independently, daily life needs help from others score 4 5, severe disability, bed rest, urinary incontinence, daily life completely dependent on others score 5 6. Death score 6	12 months post-procedure
Any death within 12 months post-procedure		12 months post-procedure
Any stroke or death within 30 days post-randomization		Within 30 days post-randomization
Procedure-related complications		Perioperative period / Within 30 days post-procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: stroke; Chronic Intracranial Artery Occlusion
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: ETP-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No