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Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis

Primary Purpose

Carotid Artery Stenting, Carotid Endarterectomy, Best Medical Treatment

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Carotid Revascularization
Medical Treatment
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Stenting focused on measuring Carotid Revascularization, Carotid Artery Stenting, Carotid Endarterectomy, Best Medical Treatment, Carotid Artery Stenosis Asymptomatic

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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;

Sites / Locations

  • Peking Union Medical College HospitalRecruiting
  • Xuanwu Hospital, Capital Medical UniversityRecruiting
  • China-Japan Friendship HospitalRecruiting
  • The Second Hospital of Hebei Medical UniversityRecruiting
  • Hebei General HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • The Fifth Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • First Affiliated Hospital Xi'an Jiaotong UniversityRecruiting
  • Shanghai Changhai HospitalRecruiting
  • People's Hospital of Xinjiang Uygur Autonomous RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Carotid Revascularization

Medical Treatment

Arm Description

Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment

Best Medical Treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Incidence of myocardial infarction
Incidence of myocardial infarction at 30 days follow up.
Incidence of ipsilateral stroke
Incidence of ipsilateral stroke at 30 days follow up.
Incidence of death
Incidence of death at 30 days follow up.
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.
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.
Improvement in cognitive function
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 30 days follow up.
Improvement in cognitive function
Cognitive function was assessed by Mini-mental State Examination (MMSE) at 30 days follow up.
Improvement in cognitive function
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 12 months follow up.
Improvement in cognitive function
Cognitive function was assessed by Mini-mental State Examination (MMSE) at 12 months follow up.

Full Information

First Posted
October 9, 2022
Last Updated
January 27, 2023
Sponsor
Xuanwu Hospital, Beijing
Collaborators
China-Japan Friendship Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University, Changhai Hospital, Peking Union Medical College Hospital, Hebei General Hospital, The Second Hospital of Hebei Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, People's Hospital of Xinjiang Uygur Autonomous Region, Fifth Affiliated Hospital of Zhengzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT05623904
Brief Title
Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis
Official Title
Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis: a Multicenter, Open, Randomized Controlled Trial in Chinese Population
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
China-Japan Friendship Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University, Changhai Hospital, Peking Union Medical College Hospital, Hebei General Hospital, The Second Hospital of Hebei Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, People's Hospital of Xinjiang Uygur Autonomous Region, Fifth Affiliated Hospital of Zhengzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenting, Carotid Endarterectomy, Best Medical Treatment, Carotid Artery Stenosis Asymptomatic
Keywords
Carotid Revascularization, Carotid Artery Stenting, Carotid Endarterectomy, Best Medical Treatment, Carotid Artery Stenosis Asymptomatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1056 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carotid Revascularization
Arm Type
Active Comparator
Arm Description
Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment
Arm Title
Medical Treatment
Arm Type
Active Comparator
Arm Description
Best Medical Treatment
Intervention Type
Procedure
Intervention Name(s)
Carotid Revascularization
Intervention Description
Carotid Artery Stenting/Carotid Endarterectomy
Intervention Type
Drug
Intervention Name(s)
Medical Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.
Description
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.
Time Frame
0 to 12 months
Secondary Outcome Measure Information:
Title
Technical success rate
Description
Technical success was defined as final residual stenosis less than 30%, TIMI grade 3, and no dissection or thrombus after any endovascular treatment.
Time Frame
1 day
Title
Rate of complications
Description
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.
Time Frame
30 days
Title
Incidence of myocardial infarction
Description
Incidence of myocardial infarction at 30 days follow up.
Time Frame
30 days
Title
Incidence of ipsilateral stroke
Description
Incidence of ipsilateral stroke at 30 days follow up.
Time Frame
30 days
Title
Incidence of death
Description
Incidence of death at 30 days follow up.
Time Frame
30 days
Title
Carotid restenosis rate
Description
Carotid restenosis was defined as restenosis ≥50% after carotid revascularization, that is, peak systolic velocity ratio (PSVR) ≥2.0 on ultrasound examination.
Time Frame
12 months
Title
Incidence of target lesion revascularization
Description
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.
Time Frame
12 months
Title
Improvement in cognitive function
Description
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 30 days follow up.
Time Frame
30 days
Title
Improvement in cognitive function
Description
Cognitive function was assessed by Mini-mental State Examination (MMSE) at 30 days follow up.
Time Frame
30 days
Title
Improvement in cognitive function
Description
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 12 months follow up.
Time Frame
12 months
Title
Improvement in cognitive function
Description
Cognitive function was assessed by Mini-mental State Examination (MMSE) at 12 months follow up.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongquan Gu, Dr.
Phone
+8615901598209
Email
gu15901598209@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xixiang Gao, Dr.
Phone
+8613581674309
Email
vascsurgeon@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongquan Gu, Dr.
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuehong Zheng, MD
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianrui Guo, MD
First Name & Middle Initial & Last Name & Degree
Xixiang Gao
Phone
+8613581674309
Email
vascsurgeon@163.com
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100192
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Liu, MD
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Bi, MD
Facility Name
Hebei General Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050057
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonan Lv, MD
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Li, MD
Facility Name
The Fifth Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Wang, MD
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoqiang Li, MD
Facility Name
First Affiliated Hospital Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianlin Liu, MD
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqing Zhao, MD
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohu Ge

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis

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