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

NCT02328781 | Completed

• 1 other identifier: BTH-PESS
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebrobasilar Insufficiency

Keywords

vertebral artery stenosis; drug-eluting stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Immediate stent implantation success rate

  Immediate after the procedure

• Any death or stroke related to the treated area

  1 year

• Any death or stroke

  1 year

Study Arms (1)

Experimental

EXPERIMENTAL

Drug-eluting stent

Device: Drug-eluting stent

Interventions

Drug-eluting stent DEVICE

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongrong Miao: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Vertebrobasilar Insufficiency

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Zhongrong Miao, PhD,MD

  Beijing Tiantan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Interventional Neuroloy Department

Study Record Dates

• First Submitted: December 28, 2014
• First Posted: December 31, 2014
• Study Start: July 17, 2014
• Primary Completion: June 14, 2016
• Study Completion: November 25, 2016
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

CN (1)