Ischemic StrokeNCT02197559
Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
An observational study of Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- DES group and BMS group
- Type of treatment
- Surgery or procedure
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jun 2016
- Phase
- Observational
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic status: as evidenced by TIA or non-severe stroke within the past 12 months attributed to 70% to 99% stenosis of vertebral artery ostium are eligible. Degree of stenosis: >70% and <99%; stenosis may be diagnosed by TCD, MRA, or CTA to qualify for angiogram performed as part of the study protocol, but must be confirmed by catheter angiography for enrollment in the trial. All the patients should be performed with PTAS beyond a duration of 3 weeks from the latest ischemic symptom onset. No fresh infarctions identified on MRI (indicated as high signals on DWI series) upon enrollment.Patient is willing and able to return for all follow-up visits required by the protocol Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.
Who may be able to join
- symptomatic posterior circulation ischemia including monor stroke (mRS ≤2) or TIA result from the stenosis in the vertebral artery ostium.
- 70% to 99% stenosis of vertebral artery ostium.
Who cannot join
- etiology of stenotic lesions not atherosclerosis patients had undergone previos interventions on the vertebral artery ostium ipsilateral severe stenotic lesions in subclavian artery involved as well as vertebral artery ostium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospectie Cohort Study of Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting
Read the detailed description
The vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in China. In the mean time ,more and more people accept revascularization. There are no prospective studies for comparison of prevention of restenosis after Drug -eluting stents and Bare-metal stents until now.
The main aim of this study is to observe the following details:
- Late loss in lumen diameter in follow-up ≥50%
- Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
- Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Secondary endpoint:
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
- Conditions
- Ischemic Stroke
- Being tested
- DES group, BMS group
- Keywords
- Ischemic Stroke, restenosis,bare-metal stents, drug -eluting stents
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DES groupProcedure or surgery
Also called Drug -eluting stents group
all the participants in this group will be performed with drug -eluting stents
BMS groupProcedure or surgery
Also called Bare-metal stents group
all the participants in this group will be performed with bare-metal stents
| Study group | Role | What they receive |
|---|---|---|
| BMS group, DES group | All the participants in this group will be performed with bare-metal stents or drug -eluting stents Receives: Procedure: DES group; Procedure: BMS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late loss in lumen diameter in follow-up ≥50%
Late loss in lumen diameter in follow-up ≥50%
Measured: 1 year
Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
Measured: 30 days
Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Measured: 12 months
Secondary outcomes (1)
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Ling, M.D., Principal investigator, Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197559
- Sponsor's protocol ID
- BEST-VAOS
- Status last verified
- Jul 2014
- First submitted
- 21 Jul 2014
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospectie Cohort Study of Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
- ClinicalTrials.gov ID
- NCT02197559
- Acronym / sponsor ID
- BEST-VAOS
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, restenosis,bare-metal stents, drug -eluting stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Jul 2014 (estimated)
- 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.
The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting
Detailed description
The vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in China. In the mean time ,more and more people accept revascularization. There are no prospective studies for comparison of prevention of restenosis after Drug -eluting stents and Bare-metal stents until now.
The main aim of this study is to observe the following details:
- Late loss in lumen diameter in follow-up ≥50%
- Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
- Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Secondary endpoint:
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS group, DES group | – | Procedure: DES group, Procedure: BMS groupAll the participants in this group will be performed with bare-metal stents or drug -eluting stents |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic status: as evidenced by TIA or non-severe stroke within the past 12 months attributed to 70% to 99% stenosis of vertebral artery ostium are eligible. Degree of stenosis: >70% and <99%; stenosis may be diagnosed by TCD, MRA, or CTA to qualify for angiogram performed as part of the study protocol, but must be confirmed by catheter angiography for enrollment in the trial. All the patients should be performed with PTAS beyond a duration of 3 weeks from the latest ischemic symptom onset. No fresh infarctions identified on MRI (indicated as high signals on DWI series) upon enrollment.Patient is willing and able to return for all follow-up visits required by the protocol Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.
Key inclusion criteria (2 listed)
- symptomatic posterior circulation ischemia including monor stroke (mRS ≤2) or TIA result from the stenosis in the vertebral artery ostium.
- 70% to 99% stenosis of vertebral artery ostium.
Key exclusion criteria (1 listed)
- etiology of stenotic lesions not atherosclerosis patients had undergone previos interventions on the vertebral artery ostium ipsilateral severe stenotic lesions in subclavian artery involved as well as vertebral artery ostium
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 |
|---|---|---|
| DES groupAlso: Drug -eluting stents groupall the participants in this group will be performed with drug -eluting stents | Procedure or surgery | BMS group, DES group |
| BMS groupAlso: Bare-metal stents groupall the participants in this group will be performed with bare-metal stents | Procedure or surgery | BMS group, DES group |
Primary outcome
Late loss in lumen diameter in follow-up ≥50%
Time frame: 1 year
Late loss in lumen diameter in follow-up ≥50%
Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
Time frame: 30 days
Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Time frame: 12 months
Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
1 secondary outcome
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
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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.
Feng Ling, M.D. principal investigator
Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late loss in lumen diameter in follow-up ≥50% (time frame: 1 year). The study lists 3 primary outcomes in all. 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 24 Oct 2016.