Endarterectomy vs Stenting in Chinese Asymptomatic Carotid Stenosis Patients

NCT03737175 | Unknown

• 1 other identifier: china carotid
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 6

Brief Summary

Endarterectomy vs Stenting Asymptomatic Carotid stenosis patients to verify the efficacy and safety.

Conditions

Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• Incidence of composite endpoints of myocardial infarction, stroke, and any death

  Incidence of composite endpoints of myocardial infarction, stroke, and any death at 30 days follow up

  30 days

Secondary Outcomes (13)

• Surgery success rate

  1 day

• Rate of complications

  30 days

• Incidence of myocardial infarction

  30 days

• Incidence of Ipsilateral stroke

  30 days

• Incidence of Bilateral stroke

  30 days

Study Arms (2)

Carotid Artery Stenting group

EXPERIMENTAL

Carotid Artery Stenting

Procedure: Carotid Artery Stenting

Carotid Endarterectomy group

ACTIVE COMPARATOR

Carotid Endarterectomy

Procedure: Carotid Endarterectomy

Interventions

Carotid Artery Stenting PROCEDURE

Carotid Artery Stenting

Carotid Artery Stenting group

Carotid Endarterectomy PROCEDURE

Carotid Endarterectomy

Carotid Endarterectomy group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical Criteria
• Age≥50 years，sex unlimited；
• Asymptomatic carotid stenosis ，ie no transient ischemic attack、stroke or other related neurological symptom caused by carotid stenosis in the past 6 months.(Only the clinical manifestations of dizziness or mild headache are considered asymptomatic carotid stenosis.)；
• The patient understands the trial objective，understands and accepts the duration of the study，is able and willing to comply with all requirements，including follow-up and evaluation of it, voluntarily participates in the study and signs Informed Consent Form.
• Anatomy Criteria
• Internal carotid artery independent disease.（ Involving or not involving adjacent common carotid arteries is permitted.）；
• Carotid stenosis satisfies one of the following criteria ：
• Ultrasonography suggests stenosis ≥ 70%，or angiography showed stenosis ≥ 60%；
• Ultrasonography suggests stenosis \< 70%，but angiography or other examination showed stenosis in an unstable state；
• Patients with bilateral carotid stenosis, the treatment time for target vessel contralateral vessels is required 30 days before enrollment or 30 days after completion of study procedure；
• The stent can reach the site of lesion smoothly as expected.

You may not qualify if:

• Clinical Criteria
• Patients with progressive stroke in the past 3 months or recent (Within 7 days)， CT or MRI suggested that the lesion is large，and may be with the risk of hemorrhagic transformation；
• Patients with anesthesia contraindications；
• Serious ipsilateral stroke occurred in the past and may confuse the judgment of the study endpoint；
• Patients with severe dementia；
• Patients with spontaneous intracerebral hemorrhage in the past 12 months；
• Large size of cerebral infarction or myocardial infarction occurred within 30 days ；
• Patients with large intracranial aneurysms (diameter\> 5mm)，and cannot be treated in advance or contemporaneous；
• Chronic total occlusion without obvious cerebral ischemia symptoms；
• Hemoglobin \<100 g/l， Platelet count \<125×109/L， INR\>1.5， Bleeding time \> 1 min，patients with exceeding the upper limits of normal，or heparin-related thrombocytopenia；
• Patients unable to perform normal angiographic evaluation or unsafe percutaneous puncture point；
• Patients with neurologic disorder that caused transient or permanent neurological deficits within 2 years before the surgery and can not be identified with transient ischemic attack or stroke；
• Patients with other 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；
• Recent gastrointestinal bleeding and affects antiplatelet therapy；
• Surgical contraindications or patients with high risk of surgery defined as having any of the following： It is known that two or more proximal or main coronary artery stenosis ≥70%, untreated or unable to pass； Ejection fraction \<30% or New York Heart Association (NYHA) functional class III or higher； Unstable angina，ie angina at resting state and electrocardiogram changes； Currently waiting main organ transplants (ie heart, lung, liver, kidney), or are doing relevant evaluate； Malignant tumor or respiratory insufficiency, life expectancy \< 5 years or forced expiratory volume at one second \< 30% (predicted)； Dialysis-dependent renal failure； Poor control of diabetes, fasting blood glucose \>22mmol/L and ketone body \> +2； Need to perform other general anesthesia during the same period；

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Shanghai Zhongshan Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Changzheng Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (6)

Sino-Japanese Friendship Hospital

Beijing, 100000, China

NOT YET RECRUITING

Shanghai Changhai Hospital

Shanghai, 200000, China

RECRUITING

Shanghai ChangZheng Hospital

Shanghai, 200000, China

NOT YET RECRUITING

Zhongshan Hospital affiliated to Fudan University

Shanghai, 200000, China

RECRUITING

The first affiliated Hospital of Xi ' an Jiaotong University

Xi'an, 710000, China

RECRUITING

The first affiliated Hospital of Zhengzhou University

Zhengzhou, 450000, China

RECRUITING

Related Publications (3)

• Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. doi: 10.1016/S1474-4422(07)70274-0. Epub 2007 Nov 13.

  PMID: 17993293 BACKGROUND

• North American Symptomatic Carotid Endarterectomy Trial Collaborators; Barnett HJM, Taylor DW, Haynes RB, Sackett DL, Peerless SJ, Ferguson GG, Fox AJ, Rankin RN, Hachinski VC, Wiebers DO, Eliasziw M. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991 Aug 15;325(7):445-53. doi: 10.1056/NEJM199108153250701.

  PMID: 1852179 BACKGROUND

• MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis. European Carotid Surgery Trialists' Collaborative Group. Lancet. 1991 May 25;337(8752):1235-43.

  PMID: 1674060 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• YongQuan Gu YQ Gu, Prof.

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YongQuan Gu YQ Gu, Prof.

CONTACT

+8615901598209; guyongquan@xwhosp.org

JianMing Guo JM Guo

CONTACT

+8613146369562; guojianming@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 9, 2018
• Study Start: March 30, 2018
• Primary Completion: May 1, 2019
• Study Completion: April 1, 2021
• Last Updated: November 9, 2018

Record last verified: 2018-11

Locations

CN (6)