Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis

Not Applicable

Recruiting

• Conditions: Carotid Artery Stenting; Carotid Artery Stenosis Asymptomatic; Carotid Endarterectomy; Best Medical Treatment
• Interventions: Procedure: Carotid Revascularization; Drug: Medical Treatment

• Registration Number: NCT05623904
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

This is a multicenter, open, randomized controlled trial to evaluate the efficacy and safety of carotid artery stenting/carotid endarterectomy versus best medical treatment for asymptomatic carotid artery stenosis in Chinese population.

Detailed Description

This is a multicenter, open, randomized controlled trial to evaluate the efficacy and safety of carotid artery stenting/carotid endarterectomy versus best medical treatment for asymptomatic carotid artery stenosis in Chinese population. The study will be conducted at 11 centers and is expected to enroll 1056 patients.

Study Timeline

• Study First Submitted: 2022-10-09
• Study Start: 2022-10-14
• Study First Submitted QC: 2022-11-13
• Study First Posted: 2022-11-21
• Status Verified: 2022-12
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-31
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1056

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；

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carotid Revascularization	Carotid Revascularization	Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment
Carotid Revascularization	Medical Treatment	Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment
Medical Treatment	Medical Treatment	Best Medical Treatment

Primary Outcome Measures

Name	Time	Method
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.	0 to 12 months	Composite of any periprocedural stroke (ipsilateral or contralateral; major or minor), myocardial infarction, or death during1 month peri-procedural period, and postprocedural ipsilateral stroke 1 to 12-months.

Secondary Outcome Measures

Name	Time	Method
Rate of complications	30 days	Rate of complications within 30 days, complications include：Cranial nerve and peripheral nerve injury, vascular injury, non cerebral hemorrhage, wound complications as neck incision or related to puncture site, and other (such as anesthesia) complications.
Incidence of myocardial infarction	30 days	Incidence of myocardial infarction at 30 days follow up.
Technical success rate	1 day	Technical success was defined as final residual stenosis less than 30%, TIMI grade 3, and no dissection or thrombus after any endovascular treatment.
Incidence of ipsilateral stroke	30 days	Incidence of ipsilateral stroke at 30 days follow up.
Incidence of death	30 days	Incidence of death at 30 days follow up.
Carotid restenosis rate	12 months	Carotid restenosis was defined as restenosis ≥50% after carotid revascularization, that is, peak systolic velocity ratio (PSVR) ≥2.0 on ultrasound examination.
Incidence of target lesion revascularization	12 months	Target lesion revascularization (TLR) is defined as the re-percutaneous intervention or bypass grafting of the target lesion for restenosis or other complications of the target lesion. All TLR should be preclassified as clinically drived or non-clinically drived before the investigator performs angiography again.
Improvement in cognitive function	12 months	Cognitive function was assessed by Mini-mental State Examination (MMSE) at 12 months follow up.

Trial Locations

Locations (11)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

First Affiliated Hospital Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Shanghai Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China

The Fifth Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China

Hebei General Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

People's Hospital of Xinjiang Uygur Autonomous Region; 🇨🇳 Urumqi, Xinjiang, China