Back to resultsProspective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System (PESS)
Primary Purpose
Vertebrobasilar Insufficiency
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug-eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Vertebrobasilar Insufficiency focused on measuring vertebral artery stenosis, drug-eluting stent
Eligibility Criteria
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
Sites / Locations
- Beijing Tiantan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Drug-eluting stent
Outcomes
Primary Outcome Measures
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%;
Secondary Outcome Measures
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)
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.
Any death or stroke
Any death or stroke during the follow-up period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02328781
Brief Title
Prospective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System
Acronym
PESS
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 17, 2014 (Actual)
Primary Completion Date
June 14, 2016 (Actual)
Study Completion Date
November 25, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhongrong Miao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebrobasilar Insufficiency
Keywords
vertebral artery stenosis, drug-eluting stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Drug-eluting stent
Intervention Type
Device
Intervention Name(s)
Drug-eluting stent
Primary Outcome Measure Information:
Title
rate of in-stent restenosis
Description
DSA angiography performed after 6 months (± 30 days) showed the occurrence of in-stent restenosis and the restenosis rate ≥ 50%;
Time Frame
6 months (± 30 days) after procedure
Secondary Outcome Measure Information:
Title
Immediate stent implantation success rate
Description
postoperative angiography immediately after implantation of Firehorus indicated that residual stenosis ≤ 20% (the degree of stenosis is determined according to the WASID method)
Time Frame
Immediate after the procedure
Title
Any death or stroke related to the treated area
Description
Any death or stroke related to the treated area supplied by the target blood vessels during the follow-up period.
Time Frame
1 year
Title
Any death or stroke
Description
Any death or stroke during the follow-up period
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongrong Miao, PhD,MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
12. IPD Sharing Statement
Learn more about this trial
Prospective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System
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