Chronic Intracranial Artery Occlusion
Conditions
Keywords
Chronic Intracranial Artery Occlusion, stroke
Brief summary
Comparison of the efficacy and safety of endovascular treatment versus medical treatment in patients with chronic intracranial artery occlusion.
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.
Interventions
PROCEDUREEndovascular 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.
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.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke or death within 30 days after enrollment, or any ischemic stroke of the qualifying artery after 30 days through 12 months after enrollment | Within 30 days post-enrollment; and 30 days to 12 months post-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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disabling stroke within 12 months post-procedure | 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. |
| Successful reperfusion rate | End of the procedure | — |
| Any stroke within 12 months post-procedure | 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. |
| Residual stenosis of target vessel at 12 months | 12 months post-procedure | The degree of target artery stenosis based on following-up neurovascular imaging |
| Fatal stroke within 12 months post-procedure | 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 |
| NIHSS score at 12 months | 12 months post-procedure | 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. |
| mRS score at 12 months | 12 months post-procedure | 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 |
| 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 | — |
Contacts
CONTACTBo Hu, Doctor
Outcome results
None listed