Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Recruiting

CT.gov ID

NCT05623904

Collaborator

China-Japan Friendship Hospital (Other), First Affiliated Hospital Xi'an Jiaotong University (Other), The First Affiliated Hospital of Zhengzhou University (Other), Changhai Hospital (Other), Peking Union Medical College Hospital (Other), Hebei General Hospital (Other), The Second Hospital of Hebei Medical University (Other), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), People's Hospital of Xinjiang Uygur Autonomous Region (Other), Fifth Affiliated Hospital of Zhengzhou University (Other)

1,056

Enrollment

Locations

Arms

37.6

Anticipated Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Stenting Carotid Endarterectomy Best Medical Treatment Carotid Artery Stenosis Asymptomatic	Procedure: Carotid Revascularization Drug: Medical Treatment	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1056 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 14, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Carotid Revascularization Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment	Procedure: Carotid Revascularization Carotid Artery Stenting/Carotid Endarterectomy Drug: Medical Treatment Aspirin 100mg/ day plus clopidogrel 75mg/ day for the first three months after enrollment or revascularization, aspirin 100mg/ day after three months, and the statin dose was adjusted according to blood lipids levels. Best medical treatment also includes risk factor control: good lifestyle, smoking cessation, weight control, regular exercise, SBP < 140 mmHg, HDL < 70 mg/dl (1.8mmol/L), and glycemic control. Patients with poor control of risk factors were dynamically adjusted during follow-up. In addition, patients undergoing CAS received dual antiplatelet therapy for at least 3 to 5 days before surgery, and patients undergoing CEA also received a preoperative oral antiplatelet drug (aspirin 100mg/ day, or clopidogrel 75mg/ day) for at least 3 days after enrollment.
Active Comparator: Medical Treatment Best Medical Treatment	Drug: Medical Treatment Aspirin 100mg/ day plus clopidogrel 75mg/ day for the first three months after enrollment or revascularization, aspirin 100mg/ day after three months, and the statin dose was adjusted according to blood lipids levels. Best medical treatment also includes risk factor control: good lifestyle, smoking cessation, weight control, regular exercise, SBP < 140 mmHg, HDL < 70 mg/dl (1.8mmol/L), and glycemic control. Patients with poor control of risk factors were dynamically adjusted during follow-up. In addition, patients undergoing CAS received dual antiplatelet therapy for at least 3 to 5 days before surgery, and patients undergoing CEA also received a preoperative oral antiplatelet drug (aspirin 100mg/ day, or clopidogrel 75mg/ day) for at least 3 days after enrollment.

Arm

Intervention/Treatment

Active Comparator: Carotid Revascularization

Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment

Procedure: Carotid Revascularization

Carotid Artery Stenting/Carotid Endarterectomy

Drug: Medical Treatment

Aspirin 100mg/ day plus clopidogrel 75mg/ day for the first three months after enrollment or revascularization, aspirin 100mg/ day after three months, and the statin dose was adjusted according to blood lipids levels. Best medical treatment also includes risk factor control: good lifestyle, smoking cessation, weight control, regular exercise, SBP < 140 mmHg, HDL < 70 mg/dl (1.8mmol/L), and glycemic control. Patients with poor control of risk factors were dynamically adjusted during follow-up. In addition, patients undergoing CAS received dual antiplatelet therapy for at least 3 to 5 days before surgery, and patients undergoing CEA also received a preoperative oral antiplatelet drug (aspirin 100mg/ day, or clopidogrel 75mg/ day) for at least 3 days after enrollment.

Active Comparator: Medical Treatment

Best Medical Treatment

Drug: Medical Treatment

Outcome Measures

Primary Outcome Measures

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

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.
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.
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 [30 days]
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 30 days follow up.
Improvement in cognitive function [30 days]
Cognitive function was assessed by Mini-mental State Examination (MMSE) at 30 days follow up.
Improvement in cognitive function [12 months]
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 12 months follow up.
Improvement in cognitive function [12 months]
Cognitive function was assessed by Mini-mental State Examination (MMSE) at 12 months follow up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100032
2	Xuanwu Hospital, Capital Medical University	Beijing	Beijing	China	100053
3	China-Japan Friendship Hospital	Beijing	Beijing	China	100192
4	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050000
5	Hebei General Hospital	Shijiazhuang	Hebei	China	050057
6	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450000
7	The Fifth Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
8	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China	210008
9	First Affiliated Hospital Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061
10	Shanghai Changhai Hospital	Shanghai	Shanghai	China	200000
11	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang	China	830011