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

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

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.

Study Overview

• Status: Completed
• Conditions: Vertebrobasilar Insufficiency
• Intervention / Treatment: Device: Drug-eluting stent

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).

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Drug-eluting stent	Device: Drug-eluting stent

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhongrong Miao
• Investigators: Study Chair: Zhongrong Miao, PhD,MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2014
• Primary Completion (Actual): June 14, 2016
• Study Completion (Actual): November 25, 2016

Study Registration Dates

• First Submitted: December 28, 2014
• First Submitted That Met QC Criteria: December 30, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: drug-eluting stent; vertebral artery stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Vertebrobasilar Insufficiency
• Other Study ID Numbers: BTH-PESS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No