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Carotid Artery StentingNCT05623904

Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis

A study testing Carotid Revascularization and Medical Treatment in people with Carotid Artery Stenting and Carotid Endarterectomy, run by Xuanwu Hospital, Beijing at 11 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Carotid Revascularization and Medical Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,056 participants
Where
11 sitesChina
Study dates
14 Oct 2022to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 24Show fewer
  • 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;
  • Patients with coagulation dysfunction.
  • Poor control of diabetes, fasting blood glucose >22mmol/L and ketone body > +2；
  • Malignant tumor or respiratory insufficiency, life expectancy < 5 years.
  • Insufficiency of vital organs: forced expiratory volume at one second < 30% (predicted)； dialysis-dependent renal failure; intolerance to anesthesia;
  • Currently waiting main organ transplants (ie heart, lung, liver, kidney), or are doing relevant evaluate；
  • Need to perform other general anesthesia surgery during the same period；
  • Pregnant or lactating women；
  • Those who participated in clinical trials of other drugs or medical devices before the inclusion did not reach the end of the time limit；
  • Investigators consider the patient inappropriate to participate in this clinical trial；

Trial locations and contacts

11 sites in 1 country.

Yongquan Gu, Dr. contact

+8615901598209

gu15901598209@aliyun.com

Xixiang Gao, Dr. contact

+8613581674309

vascsurgeon@163.com

11 sites in 1 country

China11 sites, 11 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

    Yuehong Zheng, MD

    Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

    Lianrui Guo, MD

    Xixiang Gao, +8613581674309, vascsurgeon@163.com

    Recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100192

    Peng Liu, MD

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Xiaoqiang Li, MD

    Recruiting

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200000

    Zhiqing Zhao, MD

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Wei Bi, MD

    Recruiting

  • Hebei General Hospital

    Shijiazhuang, Hebei, 050057

    Bonan Lv, MD

    Recruiting

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830011

    Xiaohu Ge

    Recruiting

  • First Affiliated Hospital Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Jianlin Liu, MD

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Zhen Li, MD

    Recruiting

  • The Fifth Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Bing Wang, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Carotid Revascularization, Medical Treatment
Keywords
Carotid Revascularization, Carotid Artery Stenting, Carotid Endarterectomy, Best Medical Treatment, Carotid Artery Stenosis Asymptomatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carotid RevascularizationProcedure or surgery

    Carotid Artery Stenting/Carotid Endarterectomy

  • 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.

Study groups in NCT05623904
Study groupRoleWhat they receive
Carotid RevascularizationActive comparatorCarotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment
Receives: Procedure: Carotid Revascularization; Drug: Medical Treatment
Medical TreatmentActive comparatorBest Medical Treatment
Receives: Drug: Medical Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0 to 12 months

Secondary outcomes (11)

  1. 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.

    Measured: 1 day

  2. 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.

    Measured: 30 days

  3. Incidence of myocardial infarction

    Incidence of myocardial infarction at 30 days follow up.

    Measured: 30 days

  4. Incidence of ipsilateral stroke

    Incidence of ipsilateral stroke at 30 days follow up.

    Measured: 30 days

  5. Incidence of death

    Incidence of death at 30 days follow up.

    Measured: 30 days

  6. 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.

    Measured: 12 months

  7. 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.

    Measured: 12 months

  8. Improvement in cognitive function

    Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 30 days follow up.

    Measured: 30 days

  9. Improvement in cognitive function

    Cognitive function was assessed by Mini-mental State Examination (MMSE) at 30 days follow up.

    Measured: 30 days

  10. Improvement in cognitive function

    Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 12 months follow up.

    Measured: 12 months

  11. Improvement in cognitive function

    Cognitive function was assessed by Mini-mental State Examination (MMSE) at 12 months follow up.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start14 Oct 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,056 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05623904
Sponsor's protocol ID
CRBMACS
Status last verified
Dec 2022
First submitted
9 Oct 2022
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Carotid Revascularization and Medical Treatment in people with Carotid Artery Stenting and Carotid Endarterectomy, run by Xuanwu Hospital, Beijing at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongquan Gu, Dr. (+8615901598209, gu15901598209@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months. (time frame: 0 to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05623904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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