Carotid Revascularization Versus Best 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 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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Stenting; Carotid Endarterectomy; Best Medical Treatment; Carotid Artery Stenosis Asymptomatic
• Intervention / Treatment: Procedure: Carotid Revascularization; Drug: Medical Treatment

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 Type: Interventional
• Enrollment (Anticipated): 1056
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yongquan Gu, Dr.; Phone Number: +8615901598209; Email: gu15901598209@aliyun.com
• Study Contact Backup: Name: Xixiang Gao, Dr.; Phone Number: +8613581674309; Email: vascsurgeon@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yuehong Zheng, MD
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Lianrui Guo, MD
      • Contact: Xixiang Gao; Phone Number: +8613581674309; Email: vascsurgeon@163.com
    • Beijing, Beijing, China, 100192
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Peng Liu, MD
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China, 050057
      • Recruiting
      • Hebei General Hospital
      • Contact: Bonan Lv, MD
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Zhen Li, MD
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The fifth Affiliated Hospital of Zhengzhou University
      • Contact: Bing Wang, MD
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower hospital
      • Contact: Xiaoqiang Li, MD
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital Xi'an Jiaotong University
      • Contact: Jianlin Liu, MD
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Changhai Hospital
      • Contact: Zhiqing Zhao, MD
  • Xinjiang
    • Urumqi, Xinjiang, China, 830011
      • Recruiting
      • People's Hospital of Xinjiang Uygur Autonomous Region
      • Contact: Xiaohu Ge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Incidence of myocardial infarction	Incidence of myocardial infarction at 30 days follow up.	30 days
Incidence of ipsilateral stroke	Incidence of ipsilateral stroke at 30 days follow up.	30 days
Incidence of death	Incidence of death at 30 days follow up.	30 days
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
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
Improvement in cognitive function	Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 30 days follow up.	30 days
Improvement in cognitive function	Cognitive function was assessed by Mini-mental State Examination (MMSE) at 30 days follow up.	30 days
Improvement in cognitive function	Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 12 months follow up.	12 months
Improvement in cognitive function	Cognitive function was assessed by Mini-mental State Examination (MMSE) at 12 months follow up.	12 months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Changhai Hospital; Peking Union Medical College Hospital; The Second Hospital of Hebei Medical University; Hebei General Hospital; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of Zhengzhou University; China-Japan Friendship Hospital; People's Hospital of Xinjiang Uygur Autonomous Region; Fifth Affiliated Hospital of Zhengzhou University
• Investigators: Principal Investigator: Yongquan Gu, Dr., Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 9, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 4, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Carotid Revascularization; Carotid Artery Stenting; Carotid Endarterectomy; Best Medical Treatment; Carotid Artery Stenosis Asymptomatic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: CRBMACS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No