NCT05623904

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,056

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

October 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 31, 2023

Status Verified

December 1, 2022

Enrollment Period

3.1 years

First QC Date

October 9, 2022

Last Update Submit

January 27, 2023

Conditions

Carotid Artery StentingCarotid EndarterectomyBest Medical TreatmentCarotid Artery Stenosis Asymptomatic

Keywords

Carotid RevascularizationCarotid Artery StentingCarotid EndarterectomyBest Medical TreatmentCarotid Artery Stenosis Asymptomatic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Technical success rate

    1 day

  • Rate of complications

    30 days

  • Incidence of myocardial infarction

    30 days

  • Incidence of ipsilateral stroke

    30 days

  • Incidence of death

    30 days

  • +6 more secondary outcomes

Study Arms (2)

Carotid Revascularization

ACTIVE COMPARATOR

Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment

Procedure: Carotid RevascularizationDrug: Medical Treatment

Medical Treatment

ACTIVE COMPARATOR

Best Medical Treatment

Drug: Medical Treatment

Interventions

Carotid RevascularizationPROCEDURE

Carotid Artery Stenting/Carotid Endarterectomy

Carotid Revascularization
Medical TreatmentDRUG

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.

Carotid RevascularizationMedical Treatment

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100192, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

Hebei General Hospital

Shijiazhuang, Hebei, 050057, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

The Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830011, China

RECRUITING

Study Officials

  • Yongquan Gu, Dr.

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongquan Gu, Dr.

CONTACT

+8615901598209gu15901598209@aliyun.com

Xixiang Gao, Dr.

CONTACT

+8613581674309vascsurgeon@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2022

First Posted

November 21, 2022

Study Start

October 14, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 31, 2023

Record last verified: 2022-12

Locations

CN(11)