Clinical trial NCT02328781: Prospective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertebrobasilar Insufficiency
Keywords: vertebral artery stenosis
drug-eluting stent
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Aged over 18 years (including 18 years old), and under 80 years old (including 80 years old), male / Pregnancy Test ( -) female
2. 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)
3. DSA angiography indicated target lesion stenosis ≥ 50% (the degree of stenosis is determined according to the WASID method)
4. Length of vascular lesion ≤ 21mm
5. Modified Rankin score \< 3
6. Suiform for placing with vertebral artery rapamycin-eluting stent, voluntary to receive follow-up and sing the informed consent

Exclusion Criteria:

1. There is a series of stenosis lesion within the target lesion region
2. TIA or non- disabling stroke (such as atrial fibrillation, etc.) caused by other factors other than vertebral artery stenosis
3. The target lesion area had received previous surgery or endovascular treatment
4. 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
5. Unsuitable / intolerable to dual antiplatelet therapy
6. Suffered from cerebral infarction and severe neurological dysfunction related to the responsible blood vessels (modified Rankin score ≥ 3 points)
7. Experienced severe myocardial infarction within 2 weeks
8. Accompanied by other intracranial lesions, such as intracranial hemorrhage, aneurysm, arteriovenous malformations, brain tumors, etc.
9. Arterial dissection, moyamoya disease, arteritis active, unexplained non- atherosclerotic stenosis
10. Serious target vessel tortuosity / calcification, leading to not suitable for stenting / lesion can not be expanded
11. Severe renal impairment, or allergic to or resistant to contrast agent, rapamycin (Rapamycin) and its derivatives, cobalt based alloys, polylactic acid ;
12. Patients participated in other drugs or equipment and have not reached the endpoint
13. The patient or their family members do not agree to sign an informed consent form

Primary outcomes:
measure: rate of in-stent restenosis
timeFrame: 6 months (± 30 days) after procedure
Secondary outcomes:
measure: Immediate stent implantation success rate
timeFrame: Immediate after the procedure
measure: Any death or stroke related to the treated area
timeFrame: 1 year
measure: Any death or stroke
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Zhongrong Miao, PhD,MD
role: STUDY_CHAIR
References: