Prospective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of Firehorus vertebral artery rapamycin-target-eluting stent system (hereinafter referred to as Firehorus) in treatment of symptomatic vertebral artery stenosis.

Detailed Description
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This clinical trial utilizes the prospective, multicenter, single-arm target value trial design, to evaluate the safety and efficacy of Firehorus vertebral artery rapamycin-target-eluting stent system (hereinafter referred to as Firehorus) in clinical use, for which 5 (or more) institutions will be selected as Clinical Trial Centre.Subjects will be screened in accordance with the inclusion and exclusion criteria of the this protocol and will be treated with Firehorus. Immediate stent implantation success rate of all subjects after surgery will be recorded, DSA angiographic follow-up will be performed at six months (±30 days) after surgery to assess the incidence of stent restenosis ( stenosis ≥ 50%) of the subjects, and the subjects will be followed up at 30 days (±7 days), 6 months (± 30 days), 12 months (± 30 days) after surgery , so as to evaluate the safety and efficacy of Firehorus in clinical use. The expected participating duration of each subject from enrollment to complete the follow-up is 12 months (± 30 days).

Official Title
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Prospective Multi-center Single-arm Target Value Clinical Trial for Evaluating Clinical Use Safety and Efficacy of the Firehorus Vertebral Artery Rapamycin-target-eluting Stent System

Conditions
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Vertebrobasilar Insufficiency

Intervention / Treatment
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* Device: Drug-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 18 years (including 18 years old), and under 80 years old (including 80 years old), male / Pregnancy Test ( -) female Patients with symptomatic vertebral artery stenosis not responding to drug therapy (defined as stroke or TIA occurred within 90 days, the patient is using at least one antithrombotic drug and receiving interventions for other vascular risk factors, such as antihypertensive therapy or lipid-lowering therapy for hypertensionor high cholesterol when stroke or TIA occurs) DSA angiography indicated target lesion stenosis ≥ 50% (the degree of stenosis is determined according to the WASID method) Length of vascular lesion ≤ 21mm Modified Rankin score < 3 Suiform for placing with vertebral artery rapamycin-eluting stent, voluntary to receive follow-up and sing the informed consent Exclusion Criteria: There is a series of stenosis lesion within the target lesion region TIA or non- disabling stroke (such as atrial fibrillation, etc.) caused by other factors other than vertebral artery stenosis The target lesion area had received previous surgery or endovascular treatment Combined with severe systemic disease or with other disease with the potential risk to cause fatal sudden illness, or the subject with life expectancy <2 years Unsuitable / intolerable to dual antiplatelet therapy Suffered from cerebral infarction and severe neurological dysfunction related to the responsible blood vessels (modified Rankin score ≥ 3 points) Experienced severe myocardial infarction within 2 weeks Accompanied by other intracranial lesions, such as intracranial hemorrhage, aneurysm, arteriovenous malformations, brain tumors, etc. Arterial dissection, moyamoya disease, arteritis active, unexplained non- atherosclerotic stenosis Serious target vessel tortuosity / calcification, leading to not suitable for stenting / lesion can not be expanded Severe renal impairment, or allergic to or resistant to contrast agent, rapamycin (Rapamycin) and its derivatives, cobalt based alloys, polylactic acid ; Patients participated in other drugs or equipment and have not reached the endpoint The patient or their family members do not agree to sign an informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Drug-eluting stent | Device: Drug-eluting stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of in-stent restenosis | DSA angiography performed after 6 months (± 30 days) showed the occurrence of in-stent restenosis and the restenosis rate ≥ 50%; | 6 months (± 30 days) after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate stent implantation success rate | postoperative angiography immediately after implantation of Firehorus indicated that residual stenosis ≤ 20% (the degree of stenosis is determined according to the WASID method) | Immediate after the procedure | 
| Any death or stroke related to the treated area | Any death or stroke related to the treated area supplied by the target blood vessels during the follow-up period. | 1 year | 
| Any death or stroke | Any death or stroke during the follow-up period | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vertebral artery stenosis, drug-eluting stent