Prospective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System (NCT02328781) | Clinical Trial Compass
CompletedNot Applicable
Prospective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System
China101 participantsStarted 2014-07-17
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.