Bare-metal Stent vs Covered Stent in Chinese Patients With Subclavian Occlusive Lesions (BASELINE)

Bare-metal Stent vs Covered Stent in Chinese Patients With Subclavian Occlusive Lesions: Prospective, Multiple Center, Randomized, Open, Positive Controlled Trail

Bare-metal stent vs Covered stent with subclavian occlusive lesions to verify the efficacy and safety.Study Design are prospective, multiple center, randomized, open, positive controlled, non-inferiority trail.Case total numbers enrollment predict 408 cases，each group 204 cases.Follow up period for 1 years.

Study Overview

• Status: Unknown
• Conditions: Subclavian Occlusion
• Intervention / Treatment: Procedure: Stent implantation of subclavian artery

• Study Type: Interventional
• Enrollment (Anticipated): 408
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YongQuan Gu YQ Gu, Prof.; Phone Number: +8615901598209; Email: guyongquan@xwhosp.org
• Study Contact Backup: Name: JianMing Guo JM Guo; Phone Number: +8613146369562; Email: guojianming@aliyun.com

Study Locations

• China
  • Beijing, China, 100000
    • Not yet recruiting
    • Peking hospital first University
    • Contact: YingHua Zou YH Zou, Prof.; Phone Number: +8613801105222
  • Dalian, China, 116000
    • Not yet recruiting
    • The First Affiliated Hospital of Dalian Medical University
    • Contact: Feng Wang F Wang, Prof.; Phone Number: +8613998642840
  • Shanghai, China, 200000
    • Not yet recruiting
    • Shanghai Changhai Hospital
    • Contact: ZhiQing Zhao ZQ Zhao, Prof.; Phone Number: +8613301617866
  • Shanghai, China, 200000
    • Recruiting
    • Shanghai Changzheng Hospital
    • Contact: LeFeng Qu LF Qu, Prof.; Phone Number: +8618616505267
  • Shanghai, China, 200000
    • Recruiting
    • Zhongshan Hospital affiliated to Fudan University
    • Contact: DaQiao Guo DQ Guo, Prof.; Phone Number: +8613801785258
  • Xi'an, China, 710000
    • Recruiting
    • The first affiliated Hospital of Xi ' an Jiaotong University
    • Contact: JianLin Liu JL Liu, Prof.; Phone Number: +8613709250539

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age≥50 years，sex unlimited；
2. Left subclavian artery disease；
3. The cause of clinical considerations is arteriosclerosis ；
4. The presence of target organ ischemic symptoms, ie dizziness, headache, transient ischemic attack (TIA), stroke, or other related neurological symptoms caused by ischemia of the vertebral artery in the past 6 months, or the presence of arterial stenosis beyond the upper extremity limb ischemia symptoms subclavian；

5. 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

6. Subclavian artery independent disease（Do not merge carotid or vertebral artery disease ）；

7. Subclavian artery satisfies one of the following criteria：

   1. a) Ultrasonography suggests stenosis ≥ 70%，or CT ANGIOGRAM / angiography showed stenosis ≥ 70%；
   2. Iconography examination confirmed vertebral artery steals；
   3. Length of lesion is not involved in vertebral artery opening；
   4. Lesions in subclavian artery the beginning portion；
8. The stent can reach the site of lesion smoothly as expected.

Exclusion Criteria:

1. Patients with anesthesia contraindications；
2. Serious ipsilateral stroke occurred in the past and may confuse the judgment of the study endpoint ；
3. Patients with severe dementia ；
4. Patients with spontaneous intracerebral hemorrhage in the past 12 months ；
5. Patients stroke episodes recently， CT or MRI suggested that the lesion is large，and may be with the risk of hemorrhagic transformation ；
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. Patients with hemorrhagic transformation of cerebral arterial thrombosis within 60 days before surgery ；
10. 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 ；
11. Patients unable to perform normal angiographic evaluation or unsafe percutaneous puncture poin；
12. Patients with neurologic disorder that caused transient or permanent neurological deficits within 2 years before the surgery and can not be identified with TIA or stroke ；
13. 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；
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； 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； 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；Subclavian artery dissection；Lesions series；Severe long segment calcification of the subclavian artery and severe stenosis or occlusion of the basilar 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.
18. Rheumatic immune diseases, such as Takayasu arteritis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Covered stent group; Covered stent	Procedure: Stent implantation of subclavian artery; Stent implantation of subclavian artery
Active Comparator: Bare-metal stent group; Bare-metal stent	Procedure: Stent implantation of subclavian artery; Stent implantation of subclavian artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
target lesion patency rate（%）	12-month target lesion patency rate（%）	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery success rate	Surgery success rate	1 day
Rate of complications	Rate of complications within 30 days；	30 days
Incidence of myocardial infarction	Incidence of myocardial infarction at 30 days follow up；	30 days
Ipsilateral stroke and death rates	Ipsilateral stroke and death rates at 30 days follow up；	30 days
Bilateral stroke and death rates	Bilateral stroke and death rates at 30 days follow up；	30 days
Subclavian artery restenosis rate	Subclavian artery restenosis rate at 6、12 months follow up；	6、12 months
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	30days
Incidence of composite endpoints of myocardial infarction, stroke, and any death	Incidence of composite endpoints of myocardial infarction, stroke, and any death at 6 months	6 months
Incidence of composite endpoints of myocardial infarction, stroke, and any death	Incidence of composite endpoints of myocardial infarction, stroke, and any death at 12 months	12 months
Surgical time	Surgical time	Through hospital stay，an average of 10 days
Hospitalization days	Hospitalization days	Through hospital stay，an average of 10 days
Hospitalization fees	Hospitalization fees	Through hospital stay，an average of 10 days

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Peking University First Hospital; Shanghai Zhongshan Hospital; First Affiliated Hospital Xi'an Jiaotong University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Changzheng Hospital; The First Affiliated Hospital of Dalian Medical University
• Investigators: Principal Investigator: YongQuan Gu YQ Gu, Prof., Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Anticipated): April 3, 2020
• Study Completion (Anticipated): July 3, 2020

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: china subclavian

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No