Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis

Carotid Endarterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623904
• Other study ID #: CRBMACS
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2022
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: Xuanwu Hospital, Beijing
• Contact: Yongquan Gu, Dr.
• Phone: +8615901598209
• Email: gu15901598209[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1056
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Best Medical Treatment
• Carotid Artery Stenting
• Carotid Endarterectomy
• Carotid Stenosis
• Constriction, Pathologic

Intervention

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.

Locations

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

Sponsors (11)

Lead Sponsor

Collaborator

Xuanwu Hospital, Beijing

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 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.	0 to 12 months
Secondary	Technical success rate	Technical success was defined as final residual stenosis less than 30%, TIMI grade 3, and no dissection or thrombus after any endovascular treatment.	1 day
Secondary	Rate of complications	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.	30 days
Secondary	Incidence of myocardial infarction	Incidence of myocardial infarction at 30 days follow up.	30 days
Secondary	Incidence of ipsilateral stroke	Incidence of ipsilateral stroke at 30 days follow up.	30 days
Secondary	Incidence of death	Incidence of death at 30 days follow up.	30 days
Secondary	Carotid restenosis rate	Carotid restenosis was defined as restenosis =50% after carotid revascularization, that is, peak systolic velocity ratio (PSVR) =2.0 on ultrasound examination.	12 months
Secondary	Incidence of target lesion revascularization	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.	12 months
Secondary	Improvement in cognitive function	Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 30 days follow up.	30 days
Secondary	Improvement in cognitive function	Cognitive function was assessed by Mini-mental State Examination (MMSE) at 30 days follow up.	30 days
Secondary	Improvement in cognitive function	Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 12 months follow up.	12 months
Secondary	Improvement in cognitive function	Cognitive function was assessed by Mini-mental State Examination (MMSE) at 12 months follow up.	12 months