Clinical trial NCT05623904: Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis
Official title: Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis: a Multicenter, Open, Randomized Controlled Trial in Chinese Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carotid Artery Stenting
Carotid Endarterectomy
Best Medical Treatment
Carotid Artery Stenosis Asymptomatic
Keywords: Carotid Revascularization
Carotid Artery Stenting
Carotid Endarterectomy
Best Medical Treatment
Carotid Artery Stenosis Asymptomatic
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: The First Affiliated Hospital of Zhengzhou University
name: Changhai Hospital
name: Peking Union Medical College Hospital
name: Hebei General Hospital
name: The Second Hospital of Hebei Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: Fifth Affiliated Hospital of Zhengzhou University
First posted: 2022-11-21
Enrollment: 1056
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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；

Primary outcomes:
measure: Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.
timeFrame: 0 to 12 months
Secondary outcomes:
measure: Technical success rate
timeFrame: 1 day
measure: Rate of complications
timeFrame: 30 days
measure: Incidence of myocardial infarction
timeFrame: 30 days
measure: Incidence of ipsilateral stroke
timeFrame: 30 days
measure: Incidence of death
timeFrame: 30 days
measure: Carotid restenosis rate
timeFrame: 12 months
measure: Incidence of target lesion revascularization
timeFrame: 12 months
measure: Improvement in cognitive function
timeFrame: 30 days
measure: Improvement in cognitive function
timeFrame: 30 days
measure: Improvement in cognitive function
timeFrame: 12 months
measure: Improvement in cognitive function
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The Fifth Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Xi'an
country: China
facility: First Affiliated Hospital Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Yongquan Gu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: