Subclavian OcclusionBASELINENCT03737162
Bare-metal Stent vs Covered Stent in Chinese Patients With Subclavian Occlusive Lesions
A study testing Stent implantation of subclavian artery in people with Subclavian Occlusion, run by Xuanwu Hospital, Beijing at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subclavian Occlusion
- What is being tested?
- Stent implantation of subclavian artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 6 sitesChina
- Study dates
- 2 Apr 2018to 3 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥50 years，sex unlimited；
- Left subclavian artery disease；
- The cause of clinical considerations is arteriosclerosis ；
- 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；
- 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
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- Subclavian artery independent disease（Do not merge carotid or vertebral artery disease ）；
- Subclavian artery satisfies one of the following criteria：
- a) Ultrasonography suggests stenosis ≥ 70%，or CT ANGIOGRAM / angiography showed stenosis ≥ 70%；
- Iconography examination confirmed vertebral artery steals；
- Length of lesion is not involved in vertebral artery opening；
- Lesions in subclavian artery the beginning portion；
- The stent can reach the site of lesion smoothly as expected.
Who cannot join
- Patients with anesthesia contraindications；
- Serious ipsilateral stroke occurred in the past and may confuse the judgment of the study endpoint ；
- Patients with severe dementia ；
- Patients with spontaneous intracerebral hemorrhage in the past 12 months ；
- Patients stroke episodes recently， CT or MRI suggested that the lesion is large，and may be with the risk of hemorrhagic transformation ；
- Large size of cerebral infarction or myocardial infarction occurred within 30 days ；
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- 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 hemorrhagic transformation of cerebral arterial thrombosis within 60 days before surgery ；
- 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 ；
- Patients unable to perform normal angiographic evaluation or unsafe percutaneous puncture poin；
- 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 ；
- 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；
- 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 ；
- 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）；
- Investigators consider the patient inappropriate to participate in this clinical trial；
- Those who participated in clinical trials of other drugs or medical devices before the inclusion did not reach the end of the time limit.
- Rheumatic immune diseases, such as Takayasu arteritis.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Peking hospital first University
Beijing, 100000
YingHua Zou YH Zou, Prof., +8613801105222
- Not yet recruiting
The first affiliated Hospital of Dalian Medical University
Dalian, 116000
Feng Wang F Wang, Prof., +8613998642840
- Not yet recruiting
Shanghai Changhai Hospital
Shanghai, 200000
ZhiQing Zhao ZQ Zhao, Prof., +8613301617866
- Recruiting
Shanghai Changzheng Hospital
Shanghai, 200000
LeFeng Qu LF Qu, Prof., +8618616505267
- Recruiting
Zhongshan Hospital affiliated to Fudan University
Shanghai, 200000
DaQiao Guo DQ Guo, Prof., +8613801785258
- Recruiting
The first affiliated Hospital of Xi ' an Jiaotong University
Xi'an, 710000
JianLin Liu JL Liu, Prof., +8613709250539
About this study
Official title: 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.
- Conditions
- Subclavian Occlusion
- Being tested
- Stent implantation of subclavian artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent implantation of subclavian arteryProcedure or surgery
Stent implantation of subclavian artery
| Study group | Role | What they receive |
|---|---|---|
| Covered stent group | Experimental | Covered stent Receives: Procedure: Stent implantation of subclavian artery |
| Bare-metal stent group | Active comparator | Bare-metal stent Receives: Procedure: Stent implantation of subclavian artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
target lesion patency rate（%）
12-month target lesion patency rate（%）
Measured: 1 years
Secondary outcomes (12)
Surgery success rate
Surgery success rate
Measured: 1 day
Rate of complications
Rate of complications within 30 days；
Measured: 30 days
Incidence of myocardial infarction
Incidence of myocardial infarction at 30 days follow up；
Measured: 30 days
Ipsilateral stroke and death rates
Ipsilateral stroke and death rates at 30 days follow up；
Measured: 30 days
Bilateral stroke and death rates
Bilateral stroke and death rates at 30 days follow up；
Measured: 30 days
Subclavian artery restenosis rate
Subclavian artery restenosis rate at 6、12 months follow up；
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Surgical time
Surgical time
Measured: Through hospital stay，an average of 10 days
Hospitalization days
Hospitalization days
Measured: Through hospital stay，an average of 10 days
Hospitalization fees
Hospitalization fees
Measured: Through hospital stay，an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start2 Apr 2018
- Primary completion3 Apr 2020 (estimated)
- Study completion3 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclavian OcclusionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Yong-Quan Gu, Xuanwu Hospital, Beijing
- Investigators
- YongQuan Gu YQ Gu, Prof., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737162
- Sponsor's protocol ID
- china subclavian
- Acronym
- BASELINE
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bare-metal Stent vs Covered Stent in Chinese Patients With Subclavian Occlusive Lesions: Prospective, Multiple Center, Randomized, Open, Positive Controlled Trail
- ClinicalTrials.gov ID
- NCT03737162
- Acronym / sponsor ID
- BASELINE / china subclavian
- Conditions
- Subclavian Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- 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
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 3 Apr 2020 (estimated)
- Study completion
- 3 Jul 2020 (estimated)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covered stent group | Experimental | Procedure: Stent implantation of subclavian arteryCovered stent |
| Bare-metal stent group | Active comparator | Procedure: Stent implantation of subclavian arteryBare-metal stent |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age≥50 years，sex unlimited；
- Left subclavian artery disease；
- The cause of clinical considerations is arteriosclerosis ；
- 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；
- 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.
Key exclusion criteria (18 listed)
- Patients with anesthesia contraindications；
- Serious ipsilateral stroke occurred in the past and may confuse the judgment of the study endpoint ；
- Patients with severe dementia ；
- Patients with spontaneous intracerebral hemorrhage in the past 12 months ；
- Patients stroke episodes recently， CT or MRI suggested that the lesion is large，and may be with the risk of hemorrhagic transformation ；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent implantation of subclavian arteryStent implantation of subclavian artery | Procedure or surgery | Bare-metal stent group, Covered stent group |
Primary outcome
target lesion patency rate（%）
Time frame: 1 years
12-month target lesion patency rate（%）
12 secondary outcomes
Surgery success rate
Time frame: 1 day
Rate of complications
Time frame: 30 days
Incidence of myocardial infarction
Time frame: 30 days
Ipsilateral stroke and death rates
Time frame: 30 days
Bilateral stroke and death rates
Time frame: 30 days
Subclavian artery restenosis rate
Time frame: 6、12 months
Incidence of composite endpoints of myocardial infarction, stroke, and any death
Time frame: 30days
Incidence of composite endpoints of myocardial infarction, stroke, and any death
Time frame: 6 months
Incidence of composite endpoints of myocardial infarction, stroke, and any death
Time frame: 12 months
Surgical time
Time frame: Through hospital stay，an average of 10 days
Hospitalization days
Time frame: Through hospital stay，an average of 10 days
Hospitalization fees
Time frame: Through hospital stay，an average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YongQuan Gu YQ Gu, Prof. principal investigator
Xuanwu Hospital, Beijing
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent implantation of subclavian artery in people with Subclavian Occlusion, run by Xuanwu Hospital, Beijing at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YongQuan Gu YQ Gu, Prof. (+8615901598209, guyongquan@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target lesion patency rate（%） (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.