Treatment options for patients with non-acute carotid artery occlusion

Revascularization for Symptomatic Non-acute Carotid Artery Occlusion

This study is testing three different surgical treatments for patients with blocked carotid arteries to see which one works best and is safest for those who have had symptoms for at least a day.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06303414 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to evaluate the success rate, efficacy, and safety of recanalization treatments for non-acute carotid artery occlusion. It will compare three different surgical approaches: Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS), and hybrid surgery. The study focuses on patients who have experienced ischemic symptoms and have confirmed occlusion for at least 24 hours. By analyzing outcomes from these interventions, the study seeks to provide insights into the best treatment options for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with symptomatic non-acute carotid artery occlusion confirmed by imaging.

Not a fit: Patients with recent unstable cardiac conditions or other significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with non-acute carotid artery occlusion, potentially reducing the risk of stroke recurrence.

How similar studies have performed: Previous studies have shown promise for recanalization treatments, but this study aims to provide more definitive evidence through a larger sample size.

Eligibility criteria

Inclusion Criteria:

1. Older than 18 years old;
2. Sign the informed consent form;
3. Carotid occlusion at least 24h;
4. Patients with clinical localization symptoms: ipsilateral hemisphere ischemia symptoms or ipsilateral eye ischemia symptoms or cognition impairment, with or without anterior circulation blood supply area infarction;
5. DSA confirmed common carotid artery or internal carotid artery (mTICI=0) occlusion;
6. Perfusion imaging confirms the presence of hypoperfusion in the corresponding area(CBF decrease);
7. The optimal medical treatment for patients who still have ischemic symptoms;
8. Routine DWI and ADC sequence examinations are performed before surgery no new infarction;

Exclusion Criteria:

1. Intracranial arteriovenous malformation or aneurysm;
2. Unstable angina, myocardial infarction (MI), or congestive heart failure in the last 6 months;
3. Uncontrolled diabetes mellitus defined as glucose \> 300 mg/dL (16.67 mmol/L);
4. Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure;
5. Pregnant or in the perinatal period;
6. Severe concomitant disease with poor prognosis (life expectancy \< 3 years);
7. Intolerance or allergies to any of the study medications, such as aspirin or clopidogrel;
8. Allergy to iodine or radiographic contrast media;
9. Concomitant vascular conditions precluding endovascular;
10. Patients with large cerebral infarction within 2 weeks;
11. History of ipsilateral vocal cord paralysis;
12. Those with severe skin diseases who are expected to have difficulty healing the incision;
13. Poor functional status before onset (mRS score 4-5 points).
14. The area of infarction in the occluded vascular area exceeds half of the vascular supply area;
15. Already have dementia or psychiatric illness and are unable to complete neurological and cognitive assessments.
16. Any condition that in the surgeon's judgment suggests the patient an unsuitable surgical candidate.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Xuanwu Hospital, Capital Medical University. — Beijing, China (RECRUITING)

Conditions: Non-acute Carotid Artery Occlusion