Clinical trial NCT03201432: Drug Eluting Stents Versus Bare Metal Stents for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis
Official title: A Randomized Trial for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis: Drug Eluting Stents Versus Bare Metal Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ischemic Stroke
Vertebral Artery Stenosis
Keywords: Vertebral Artery Stenosis
Ischemic Stroke
Stent
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Yinyi(Liaoning) Biotech Co., Ltd.
First posted: 2017-06-28
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Stent restenosis rate 6 months after stenting
timeFrame: 6 months
Secondary outcomes:
measure: Stent restenosis rate 3 months after stenting
timeFrame: 3 months
measure: Stent restenosis rate 12 months after stenting
timeFrame: 12 months
measure: The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiongjing Jiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: