Endovascular Treatment of Chronic Intracranial Artery Occlusion

NCT07699003 | Not Yet Recruiting

• 1 other identifier: ETP-C
• Study Type: interventional
• Target: 382
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Intracranial Artery Occlusion

Keywords

Chronic Intracranial Artery Occlusion; stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Disabling stroke within 12 months post-procedure

  12 months post-procedure

• Successful reperfusion rate

  End of the procedure

• Any stroke within 12 months post-procedure

  12 months post-procedure

• Residual stenosis of target vessel at 12 months

  12 months post-procedure

• Fatal stroke within 12 months post-procedure

  12 months post-procedure

Study Arms (2)

Test group

EXPERIMENTAL

Endovascular treatment combined with standard pharmacological treatment

Procedure: Endovascular treatment

control group

OTHER

Standard pharmacological treatment

Drug: Standard pharmacological treatment

Interventions

Endovascular treatment PROCEDURE

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.

Test group

Standard pharmacological treatment DRUG

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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• 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)
• Modified Rankin Scale (mRS) score of 0-2
• 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
• The subject or their legally authorised representative has provided written informed consent for the study

You may not qualify if:

• Evidence of hemorrhage on CT or MRI
• Large hemispheric infarction involving \>50% of the middle cerebral artery territory on CT or MRI
• Severe pre-stroke disability (modified Rankin Scale score ≥2) or life expectancy \<12 months
• Major comorbidities that may interfere with outcome assessment and follow-up (e.g., severe heart failure, renal failure, etc.)
• Uncontrolled seizure at the time of stroke onset
• Baseline platelet count \<50,000/μL
• Severe, persistent hypertension that remains uncontrolled despite active management (systolic blood pressure \>220 mmHg or diastolic blood pressure \>120 mmHg)
• Known inherited or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an international normalized ratio (INR) \>3
• Suspected septic emboli or suspected bacterial endocarditis
• Known allergy to iodine, heparin, or anaesthetics, or other definite contraindications to endovascular procedures
• Pregnant women
• Other severe, progressive, or terminal diseases (as judged by the investigator), or life expectancy \<24 months
• Prior attempted endovascular recanalization therapy before randomization
• Current participation in other studies involving investigational drugs or devices
• Evidence of intracranial tumour on CT or MRI (except meningioma)

Sponsors & Collaborators

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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Bo Hu, Doctor

CONTACT

+86 13707114863; hubo@mail.hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Neurology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share