Ischemic StrokePhase 2/3NCT03201432

Drug Eluting Stents Versus Bare Metal Stents for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis

A Phase 2/3 study testing Drug eluting stent (DES) and Bare metal stent (BES) in people with Ischemic Stroke and Vertebral Artery Stenosis, run by Xiongjing Jiang.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Ischemic Stroke, Vertebral Artery Stenosis
What is being tested?: Drug eluting stent (DES) and Bare metal stent (BES)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: No sites listed yet
Study dates: May 2014to Jan 2017
Phase: Phase 2/3
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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic posterior circulation ischemia（Vertebral basilar artery system TIA or non-disabling ischemic stroke）result from the stenosis in the extracranial proximal vertebral artery stenosis.
Atherosclerotic extracranial proximal vertebral artery stenosis demonstrated by angiography(any of the following): 1) bilateral vertebral artery stenosis ≥70%, or vertebral artery stenosis ≥70% concomitant occlusion of contralateral vertebral artery; 2) superior lateral vertebral artery stenosis ≥70%; 3) non-superior lateral vertebral artery stenosis ≥50%, but the vertebral artery was directly extended to the posterior inferior cerebellar artery on this side and symptoms were related to insufficiency of the ipsilateral posterior inferior cerebellar artery.

Who cannot join

1) lesions characteristics (such as diffuse lesions) which was not suitable for interventional treatment, or unstable condition that cannot tolerate the interventional therapy;
2) vertebral artery stenosis caused by non atherosclerosis disease: Takayasu arteritis or other diseases;
3) severe stroke within 3 months;
4) contraindicated using contrast agents: such as chronic renal insufficiency or had serious contrast agents allergy history;
5) malignant tumor;
6) with Alzheimer's disease or mental illness previously or currently ;
7) patients or family members refuse the operation.

About this study

Official title: A Randomized Trial for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis: Drug Eluting Stents Versus Bare Metal Stents

Stroke is one of the important causes of disability and death in the world, in which more than half were ischemic strokes. About 1/4 of the ischemic stroke occurred in the vertebral basilar artery system, especially when in the presence of extracranial proximal vertebral artery stenosis. Vertebral artery stenting is a minimally invasive method for the reconstruction of vertebral artery stenosis and the early clinical studies showed that it was feasible, safe and effective, but the high rate of restenosis has become a bottleneck restricting its development. Previous systematic review had suggested that the drug eluting stent might reduce the incidence of restenosis of vertebral artery. However, prospective randomized controlled trials comparing the efficacy of bare metal stents and drug eluting stents on the prevention of restenosis remains absent.

Read the detailed description

60 patients were randomly assigned into DES and BES group to compare the safety and efficacy in the treatment of symptomatic extracranial vertebral artery stenosis with drug eluting stents (YINYI) and bare metal stents (Express SD), especially the stent restenosis rate after 6 months.

Conditions: Ischemic Stroke, Vertebral Artery Stenosis
Being tested: Drug eluting stent (DES), Bare metal stent (BES)
Keywords: Vertebral Artery Stenosis, Ischemic Stroke, Stent
Medical subject headings: Ischemic Stroke, Vertebrobasilar Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug eluting stent (DES)Device
Also called YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.)
Polymer-free paclitaxel eluting stents
Bare metal stent (BES)Device
Also called Express SD (Bosten Scientific)
Bare metal stent

Study groups in NCT03201432
Study group	Role	What they receive
Bare metal stent (BES) group	Other	Percutaneous vertebral artery stenting using bare metal stents (Boston Scientific：Express SD) in patients randomized to BES group Receives: Device: Bare metal stent (BES)
Drug eluting stent (DES) group	Experimental	Percutaneous vertebral artery stenting using drug eluting stents (Liaoning Biomedical Materials R\&D Center Co., Ltd. ：YINYI) in patients randomized to DES group Receives: Device: Drug eluting stent (DES)

What is being measured

The primary outcome is the main question the study is designed to answer.

Stent restenosis rate 6 months after stenting
Measured: 6 months

Secondary outcomes (3)

Stent restenosis rate 3 months after stenting
Measured: 3 months
Stent restenosis rate 12 months after stenting
measured by ultrasound
Measured: 12 months
The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jan 2017

First posted28 Jun 2017
Study startMay 2014
Primary completionJan 2017
Study completionJan 2017

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.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03201432
Sponsor's protocol ID: 2014-ZX15
Status last verified: Jun 2017
First submitted: 4 Mar 2016
Last updated: 28 Jun 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis: Drug Eluting Stents Versus Bare Metal Stents
ClinicalTrials.gov ID: NCT03201432
Acronym / sponsor ID: 2014-ZX15
Conditions: Ischemic Stroke, Vertebral Artery Stenosis
Keywords: Vertebral Artery Stenosis, Ischemic Stroke, Stent
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Xiongjing JiangUniversity, hospital or other
Collaborators: Yinyi(Liaoning) Biotech Co., Ltd.
Study start: May 2014
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 28 Jun 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bare metal stent (BES) group	Other	Device: Bare metal stent (BES)Percutaneous vertebral artery stenting using bare metal stents (Boston Scientific：Express SD) in patients randomized to BES group
Drug eluting stent (DES) group	Experimental	Device: Drug eluting stent (DES)Percutaneous vertebral artery stenting using drug eluting stents (Liaoning Biomedical Materials R\&D Center Co., Ltd. ：YINYI) in patients randomized to DES group

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Symptomatic posterior circulation ischemia（Vertebral basilar artery system TIA or non-disabling ischemic stroke）result from the stenosis in the extracranial proximal vertebral artery stenosis.
Atherosclerotic extracranial proximal vertebral artery stenosis demonstrated by angiography(any of the following): 1) bilateral vertebral artery stenosis ≥70%, or vertebral artery stenosis ≥70% concomitant occlusion of contralateral vertebral artery; 2) superior lateral vertebral artery stenosis ≥70%; 3) non-superior lateral vertebral artery stenosis ≥50%, but the vertebral artery was directly extended to the posterior inferior cerebellar artery on this side and symptoms were related to insufficiency of the ipsilateral posterior inferior cerebellar artery.

Key exclusion criteria (7 listed)

1) lesions characteristics (such as diffuse lesions) which was not suitable for interventional treatment, or unstable condition that cannot tolerate the interventional therapy;
2) vertebral artery stenosis caused by non atherosclerosis disease: Takayasu arteritis or other diseases;
3) severe stroke within 3 months;
4) contraindicated using contrast agents: such as chronic renal insufficiency or had serious contrast agents allergy history;
5) malignant tumor;

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
Drug eluting stent (DES)Also: YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.)Polymer-free paclitaxel eluting stents	Device	Drug eluting stent (DES) group
Bare metal stent (BES)Also: Express SD (Bosten Scientific)Bare metal stent	Device	Bare metal stent (BES) group

Primary outcome

Stent restenosis rate 6 months after stenting
Time frame: 6 months

3 secondary outcomes

Stent restenosis rate 3 months after stenting
Time frame: 3 months
Stent restenosis rate 12 months after stenting
Time frame: 12 months
The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting
Time frame: 6 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 28 Jun 2017.
Individual participant dataSharing planned: No

Related trials for Ischemic Stroke

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Active, not recruiting
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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.

Xiongjing Jiang, M.D. principal investigator

Chinese Academy of Medical Sciences, Fuwai Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Drug eluting stent (DES) and Bare metal stent (BES) in people with Ischemic Stroke and Vertebral Artery Stenosis, run by Xiongjing Jiang.

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 7 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Stent restenosis rate 6 months after stenting (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03201432.

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 28 Jun 2017.