Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis

Last updated: January 27, 2023
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carotid Artery Disease

Treatment

N/A

Clinical Study ID

NCT05623904
CRBMACS
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 otherneurological symptoms in the past 6 months;
  4. Patients who could complete 12 months of follow-up;
  5. Patients who signed informed consent forms.

Exclusion

Exclusion Criteria:

  1. Patients who had a TIA, stroke, or other related neurological symptoms within theprevious 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 inadvance or contemporaneous;
  4. Chronic total occlusion without obvious cerebral ischemia symptoms;
  5. Patients with neurologic disorder that caused transient or permanent neurologicaldeficits 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%, untreatedor unable to recanalize;
  13. Ejection fraction <30% or New York Heart Association (NYHA) functional class III orhigher;Unstable angina,ie angina at resting state and electrocardiogram changes;
  14. Patients with cardiac emboli sources, such as left ventricular aneurysm, intraluminalfilling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcificaortic stenosis, infective endocarditis, mitral stenosis, atrial septal defect, atrialseptal aneurysm, or left atrial myxoma;
  15. Platelet count <5×104/μL, INR>1.5, Bleeding time > 1 min, or heparin-relatedthrombocytopenia;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 doingrelevant 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 theinclusion did not reach the end of the time limit;
  24. Investigators consider the patient inappropriate to participate in this clinicaltrial;

Study Design

Total Participants: 1056
Study Start date:
October 14, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • China-Japan Friendship Hospital

    Beijing, Beijing 100192
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100032
    China

    Active - Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing 100053
    China

    Active - Recruiting

  • Hebei General Hospital

    Shijiazhuang, Hebei 050057
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • The Fifth Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • First Affiliated Hospital Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

  • Shanghai Changhai Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Urumqi, Xinjiang 830011
    China

    Active - Recruiting

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