Comparing carotid artery procedures with medical treatment for asymptomatic carotid stenosis

Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis: a Multicenter, Open, Randomized Controlled Trial in Chinese Population

This study is testing whether two types of carotid artery procedures are better than just medication for people who have narrowing of the carotid artery but don't have any symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1056 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 11 sites (Beijing, Beijing and 10 other locations)
• Trial ID: NCT05623904 on ClinicalTrials.gov

What this trial studies

This multicenter, open, randomized controlled trial aims to evaluate the efficacy and safety of carotid artery stenting and carotid endarterectomy compared to best medical treatment for patients with asymptomatic carotid artery stenosis. Conducted across 11 centers in China, the study plans to enroll 1056 patients aged 40 to 80 years who meet specific inclusion criteria. Participants will be monitored for 12 months to assess outcomes related to their treatment. The trial seeks to provide insights into the best management strategies for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 40-80 years with 50%-90% asymptomatic carotid artery stenosis.

Not a fit: Patients who have experienced a transient ischemic attack, stroke, or other neurological symptoms within the past 6 months will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help determine the most effective treatment approach for patients with asymptomatic carotid artery stenosis, potentially improving patient outcomes.

How similar studies have performed: Other studies have explored similar interventions for carotid artery stenosis, but this specific comparison in the asymptomatic population is less common, making it a valuable investigation.

Eligibility criteria

Inclusion Criteria:

1. Age 40-80 years;
2. Carotid artery stenosis 50%-90% (ultrasound, CT, or DSA);
3. Asymptomatic carotid stenosis, that is, no transient ischemic attack, stroke, or other neurological symptoms in the past 6 months;
4. Patients who could complete 12 months of follow-up;
5. Patients who signed informed consent forms.

Exclusion Criteria:

1. Patients who had a TIA, stroke, or other related neurological symptoms within the previous 6 months;
2. Patients with spontaneous intracerebral hemorrhage in the past 12 months；
3. Patients with large intracranial aneurysms (diameter\> 5mm)，and cannot be treated in advance or contemporaneous;
4. Chronic total occlusion without obvious cerebral ischemia symptoms；
5. Patients with neurologic disorder that caused transient or permanent neurological deficits and can not be identified with transient ischemic attack or stroke；
6. Patients with severe dementia;
7. Common carotid artery opening lesion；
8. Severe intracranial stenosis in tandem;
9. Carotid artery dissection;
10. Carotid artery aneurysm;
11. Myocardial infarction occurred within 30 days；
12. It is known that two or more proximal or main coronary artery stenosis ≥70%, untreated or unable to recanalize;
13. Ejection fraction \<30% or New York Heart Association (NYHA) functional class III or higher；Unstable angina，ie angina at resting state and electrocardiogram changes；
14. Patients with cardiac emboli sources, such as left ventricular aneurysm, intraluminal filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, infective endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma；
15. Platelet count \<5×104/μL, INR\>1.5, Bleeding time \> 1 min, or heparin-related thrombocytopenia；Patients contraindicated to heparin and antiplatelet drugs;
16. Patients with coagulation dysfunction.
17. Poor control of diabetes, fasting blood glucose \>22mmol/L and ketone body \> +2；
18. Malignant tumor or respiratory insufficiency, life expectancy \< 5 years.
19. Insufficiency of vital organs: forced expiratory volume at one second \< 30% (predicted)； dialysis-dependent renal failure; intolerance to anesthesia;
20. Currently waiting main organ transplants (ie heart, lung, liver, kidney), or are doing relevant evaluate；
21. Need to perform other general anesthesia surgery during the same period；
22. Pregnant or lactating women；
23. Those who participated in clinical trials of other drugs or medical devices before the inclusion did not reach the end of the time limit；
24. Investigators consider the patient inappropriate to participate in this clinical trial；

Where this trial is running

Beijing, Beijing and 10 other locations

• Peking Union Medical College Hospital — Beijing, Beijing, China (RECRUITING)
• Xuanwu Hospital, Capital Medical University — Beijing, Beijing, China (RECRUITING)
• China-Japan Friendship Hospital — Beijing, Beijing, China (RECRUITING)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (RECRUITING)
• Hebei General Hospital — Shijiazhuang, Hebei, China (RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• The Fifth Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (RECRUITING)
• First Affiliated Hospital Xi'an Jiaotong University — Xi'an, Shaanxi, China (RECRUITING)
• Shanghai Changhai Hospital — Shanghai, Shanghai, China (RECRUITING)
• People's Hospital of Xinjiang Uygur Autonomous Region — Urumqi, Xinjiang, China (RECRUITING)

Study contacts

• Principal investigator: Yongquan Gu, Dr. — Xuanwu Hospital, Beijing
• Study coordinator: Yongquan Gu, Dr.

Conditions: Carotid Artery Stenting, Carotid Endarterectomy, Best Medical Treatment, Carotid Artery Stenosis Asymptomatic, Carotid Revascularization