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Status unknownNCT03737162BASELINEUpdated Nov 9, 2018

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

An interventional study of Stent implantation of subclavian artery in Subclavian Occlusion, sponsored by Xuanwu Hospital, Beijing. Status unknown at 6 sites in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-11-09.

Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
408
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Subclavian Occlusion
03

In context

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
408 participants (estimated)

Study arms

  • Experimental
    Covered stent group

    Covered stent

    Procedure: Stent implantation of subclavian artery

  • Active comparator
    Bare-metal stent group

    Bare-metal stent

    Procedure: Stent implantation of subclavian artery

Interventions

  • ProcedureStent implantation of subclavian artery

    Stent implantation of subclavian artery

06

What researchers measure

Primary outcomes

  1. target lesion patency rate(%)

    12-month target lesion patency rate(%)

    Time frame: 1 years

Secondary outcomes

  1. Surgery success rate

    Surgery success rate

    Time frame: 1 day

  2. Rate of complications

    Rate of complications within 30 days;

    Time frame: 30 days

  3. Incidence of myocardial infarction

    Incidence of myocardial infarction at 30 days follow up;

    Time frame: 30 days

  4. Ipsilateral stroke and death rates

    Ipsilateral stroke and death rates at 30 days follow up;

    Time frame: 30 days

  5. Bilateral stroke and death rates

    Bilateral stroke and death rates at 30 days follow up;

    Time frame: 30 days

  6. Subclavian artery restenosis rate

    Subclavian artery restenosis rate at 6、12 months follow up;

    Time frame: 6、12 months

  7. 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

    Time frame: 30days

  8. 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

    Time frame: 6 months

  9. 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

    Time frame: 12 months

  10. Surgical time

    Surgical time

    Time frame: Through hospital stay,an average of 10 days

  11. Hospitalization days

    Hospitalization days

    Time frame: Through hospital stay,an average of 10 days

  12. Hospitalization fees

    Hospitalization fees

    Time frame: Through hospital stay,an average of 10 days

07

Study locations

3 of 6 sites recruiting
  • Peking hospital first University
    Beijing, 100000, China
    • YingHua Zou YH Zou, Prof. · Contact · +8613801105222
    Not yet recruiting
  • The first affiliated Hospital of Dalian Medical University
    Dalian, 116000, China
    • Feng Wang F Wang, Prof. · Contact · +8613998642840
    Not yet recruiting
  • Shanghai Changhai Hospital
    Shanghai, 200000, China
    • ZhiQing Zhao ZQ Zhao, Prof. · Contact · +8613301617866
    Not yet recruiting
  • Shanghai Changzheng Hospital
    Shanghai, 200000, China
    • LeFeng Qu LF Qu, Prof. · Contact · +8618616505267
    Recruiting
  • Zhongshan Hospital affiliated to Fudan University
    Shanghai, 200000, China
    • DaQiao Guo DQ Guo, Prof. · Contact · +8613801785258
    Recruiting
  • The first affiliated Hospital of Xi ' an Jiaotong University
    Xi'an, 710000, China
    • JianLin Liu JL Liu, Prof. · Contact · +8613709250539
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03737162
Lead sponsor
Xuanwu Hospital, Beijing
Collaborators
Peking University First Hospital, The First Affiliated Hospital of Dalian Medical University, Shanghai Zhongshan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital, First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Yong-Quan Gu (Prof., Xuanwu Hospital, Beijing) — Principal investigator
First posted
Nov 9, 2018
Start date
Apr 2, 2018
Primary completion
Apr 3, 2020 (estimated)
Completion
Jul 3, 2020 (estimated)
Last update
Nov 9, 2018

Study contacts

YongQuan Gu YQ Gu, Prof.
Contact
guyongquan@xwhosp.org
+8615901598209
JianMing Guo JM Guo
Contact
guojianming@aliyun.com
+8613146369562
YongQuan Gu YQ Gu, Prof.
principal investigator · Xuanwu Hospital, Beijing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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