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Endarterectomy vs Stenting in Chinese Asymptomatic Carotid Stenosis Patients (ESCALATE)

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ClinicalTrials.gov Identifier: NCT03737175
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
Shanghai Zhongshan Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
China-Japan Friendship Hospital
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital Xi'an Jiaotong University
Information provided by (Responsible Party):
Yong-Quan Gu, Xuanwu Hospital, Beijing

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

Condition or disease Intervention/treatment Phase
Carotid Stenosis Procedure: Carotid Artery Stenting Procedure: Carotid Endarterectomy Not Applicable

Detailed Description:
Endarterectomy vs Stenting Asymptomatic Carotid stenosis patients to verify the efficacy and safety.Study Design is a prospective, multiple center, randomized controlled trail.600 cases enrollment predict,each group including carotid artery stenting and carotid endarterectomy 300 cases.Follow-up period of 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endarterectomy vs Stenting in Chinese Asymptomatic Carotid Stenosis Patients: Prospective, Multiple Center, Randomized Controlled Trail
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : April 1, 2021

Arm Intervention/treatment
Experimental: Carotid Artery Stenting group
Carotid Artery Stenting
Procedure: Carotid Artery Stenting
Carotid Artery Stenting

Active Comparator: Carotid Endarterectomy group
Carotid Endarterectomy
Procedure: Carotid Endarterectomy
Carotid Endarterectomy




Primary Outcome Measures :
  1. Incidence of composite endpoints of myocardial infarction, stroke, and any death [ Time Frame: 30 days ]
    Incidence of composite endpoints of myocardial infarction, stroke, and any death at 30 days follow up


Secondary Outcome Measures :
  1. Surgery success rate [ Time Frame: 1 day ]
    Surgery success rate

  2. Rate of complications [ Time Frame: 30 days ]
    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;

  3. Incidence of myocardial infarction [ Time Frame: 30 days ]
    Incidence of myocardial infarction at 30 days follow up;

  4. Incidence of Ipsilateral stroke [ Time Frame: 30 days ]
    Incidence of Ipsilateral stroke at 30 days follow up;

  5. Incidence of Bilateral stroke [ Time Frame: 30 days ]
    Incidence of Bilateral stroke at 30 days follow up;

  6. Incidence of ipsilateral stroke [ Time Frame: 12 months ]
    Incidence of ipsilateral stroke at 12 months follow up;

  7. Carotid restenosis rate [ Time Frame: 12、24 months ]
    Carotid restenosis rate at 12、24 months follow up;

  8. Incidence of target lesion revascularization [ Time Frame: 6、12、24 months ]
    Incidence of target lesion revascularization at 6、12、24 months follow up;

  9. Incidence of composite endpoints of myocardial infarction, stroke, and any death [ Time Frame: 6、12、24 months ]
    Incidence of composite endpoints of myocardial infarction, stroke, and any death at 6、12、24 months follow up;

  10. Incidence of major stroke and minor stroke [ Time Frame: 6、12、24 months ]
    Incidence of major stroke and minor stroke at 6、12、24 months follow up;

  11. Surgical time [ Time Frame: Through hospital stay,an average of 10days ]
    Surgical time

  12. Hospitalization days [ Time Frame: Through hospital stay,an average of 10days ]
    Hospitalization days

  13. Hospitalization fees [ Time Frame: Through hospital stay,an average of 10days ]
    Hospitalization fees



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical Criteria

  1. Age≥50 years,sex unlimited;
  2. 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.);
  3. 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

  4. Internal carotid artery independent disease.( Involving or not involving adjacent common carotid arteries is permitted.);
  5. Carotid stenosis satisfies one of the following criteria :

    1. Ultrasonography suggests stenosis ≥ 70%,or angiography showed stenosis ≥ 60%;
    2. Ultrasonography suggests stenosis < 70%,but angiography or other examination showed stenosis in an unstable state;
  6. 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;
  7. The stent can reach the site of lesion smoothly as expected.

Exclusion Criteria:

  • Clinical Criteria

    1. 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;
    2. Patients with anesthesia contraindications;
    3. Serious ipsilateral stroke occurred in the past and may confuse the judgment of the study endpoint;
    4. Patients with severe dementia;
    5. Patients with spontaneous intracerebral hemorrhage in the past 12 months;
    6. Large size of cerebral infarction or myocardial infarction occurred within 30 days ;
    7. Patients with large intracranial aneurysms (diameter> 5mm),and cannot be treated in advance or contemporaneous;
    8. Chronic total occlusion without obvious cerebral ischemia symptoms;
    9. 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;
    10. Patients unable to perform normal angiographic evaluation or unsafe percutaneous puncture point;
    11. 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;
    12. 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;
    13. Recent gastrointestinal bleeding and affects antiplatelet therapy;
    14. 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;
    15. There may be one or more anatomical conditions affecting the normal operative approach in patients with contraindications for carotid endarterectomy operation; there may be one or more anatomic situations to increase the risk of adverse events in patients with high operative risk;including: Neck radiation therapy history; Radical neck surgery history; Inoperable lesions (ie more than C2 lesions); Spinal brake - unable to bend neck, or kyphotic deformity; Symptomatic dissection of the carotid siphon below; Common carotid artery opening lesion;present tracheotomy; Contralateral recurrent laryngeal nerve paralysis; Previously performed ipsilateral carotid endarterectomy,intracranial or subclavian arterial bypass surgery; Contralateral carotid artery occlusion; Lesions series; Severe long segment calcification of the carotid artery; Inaccessible lesions by endoluminal methods (Severe distortion of the aortic arch branch, no suitable introduction of arteries, aortic arch anatomy special);
    16. Investigators consider the patient inappropriate to participate in this clinical trial;
    17. Those who participated in clinical trials of other drugs or medical devices before the inclusion did not reach the end of the time limit.

      Angiography criteria

    18. Severe vascular tortuosity, or anatomical conditions may affect the safe locomotion of guide catheter, guide sheath or stent;
    19. Patients with ipsilateral carotid artery stenting or having a graft;
    20. Patients with severe or extensive arteriosclerosis, involving the aortic arch and the proximal common carotid artery, causing locomotion danger of guide catheter or guide sheath;
    21. Carotid endarterectomy contraindications by angiography:severity of intracranial or extracranial arterial stenosis that exceeds target lesions; cerebrovascular arteriovenous malformations; or other contraindications;
    22. Patients with contralateral carotid artery stenosis, are expected to be performed within 30 days of the perioperative period of the study;
    23. Occlusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737175


Contacts
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Contact: YongQuan Gu YQ Gu, Prof. +8615901598209 guyongquan@xwhosp.org
Contact: JianMing Guo JM Guo +8613146369562 guojianming@aliyun.com

Locations
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China
Sino-Japanese Friendship Hospital Not yet recruiting
Beijing, China, 100000
Contact: Peng Liu P Liu, Prof.    +8613701333388      
Contact: ZhiDong Ye ZD Ye    +8613910682488      
Shanghai Changhai Hospital Recruiting
Shanghai, China, 200000
Contact: ZhiQing Zhao ZQ Zhao, Prof.    +8613301617866      
Shanghai ChangZheng Hospital Not yet recruiting
Shanghai, China, 200000
Contact: LeFeng Qu LF Qu, Prof.    +8618616505267      
Zhongshan Hospital affiliated to Fudan University Recruiting
Shanghai, China, 200000
Contact: DaQiao Guo DQ Guo, Prof.    +8613801785258      
The first affiliated Hospital of Xi ' an Jiaotong University Recruiting
Xi'an, China, 710000
Contact: JianLin Liu JL Liu, Prof.    +8613709250539      
The first affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, China, 450000
Contact: Zhen Li Z Li, Prof.    +8618303710000      
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Shanghai Zhongshan Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
China-Japan Friendship Hospital
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: YongQuan Gu YQ Gu, Prof. Xuanwu Hospital, Beijing

Publications:
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Responsible Party: Yong-Quan Gu, Prof., Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03737175     History of Changes
Other Study ID Numbers: china carotid
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carotid Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases