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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

Tracking Information
First Submitted Date  ICMJE November 6, 2018
First Posted Date  ICMJE November 9, 2018
Last Update Posted Date November 9, 2018
Actual Study Start Date  ICMJE March 30, 2018
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • Surgery success rate [ Time Frame: 1 day ]
    Surgery success rate
  • 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;
  • Incidence of myocardial infarction [ Time Frame: 30 days ]
    Incidence of myocardial infarction at 30 days follow up;
  • Incidence of Ipsilateral stroke [ Time Frame: 30 days ]
    Incidence of Ipsilateral stroke at 30 days follow up;
  • Incidence of Bilateral stroke [ Time Frame: 30 days ]
    Incidence of Bilateral stroke at 30 days follow up;
  • Incidence of ipsilateral stroke [ Time Frame: 12 months ]
    Incidence of ipsilateral stroke at 12 months follow up;
  • Carotid restenosis rate [ Time Frame: 12、24 months ]
    Carotid restenosis rate at 12、24 months follow up;
  • Incidence of target lesion revascularization [ Time Frame: 6、12、24 months ]
    Incidence of target lesion revascularization at 6、12、24 months follow up;
  • 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;
  • 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;
  • Surgical time [ Time Frame: Through hospital stay,an average of 10days ]
    Surgical time
  • Hospitalization days [ Time Frame: Through hospital stay,an average of 10days ]
    Hospitalization days
  • Hospitalization fees [ Time Frame: Through hospital stay,an average of 10days ]
    Hospitalization fees
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endarterectomy vs Stenting in Chinese Asymptomatic Carotid Stenosis Patients
Official Title  ICMJE Endarterectomy vs Stenting in Chinese Asymptomatic Carotid Stenosis Patients: Prospective, Multiple Center, Randomized Controlled Trail
Brief Summary Endarterectomy vs Stenting Asymptomatic Carotid stenosis patients to verify the efficacy and safety.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carotid Stenosis
Intervention  ICMJE
  • Procedure: Carotid Artery Stenting
    Carotid Artery Stenting
  • Procedure: Carotid Endarterectomy
    Carotid Endarterectomy
Study Arms  ICMJE
  • Experimental: Carotid Artery Stenting group
    Carotid Artery Stenting
    Intervention: Procedure: Carotid Artery Stenting
  • Active Comparator: Carotid Endarterectomy group
    Carotid Endarterectomy
    Intervention: Procedure: Carotid Endarterectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: YongQuan Gu YQ Gu, Prof. +8615901598209 guyongquan@xwhosp.org
Contact: JianMing Guo JM Guo +8613146369562 guojianming@aliyun.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03737175
Other Study ID Numbers  ICMJE china carotid
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yong-Quan Gu, Xuanwu Hospital, Beijing
Study Sponsor  ICMJE Xuanwu Hospital, Beijing
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: YongQuan Gu YQ Gu, Prof. Xuanwu Hospital, Beijing
PRS Account Xuanwu Hospital, Beijing
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP