Back to resultsStudy of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
Primary Purpose
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug eluting peripheral vascular stent system
Nitinol Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring peripheral arterial disease, Drug eluting peripheral vascular stent system, primary patency
Eligibility Criteria
Inclusion Criteria in Preoperative:
- Aged from 18 to 85 years old, male or female
- Subject's target lesions were stenosis and/or occlusion
- Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent
Exclusion Criteria in Preoperative:
- In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration
- Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration
- Subject with coagulation abnormalities should not be performed
Sites / Locations
- West China Hospital, Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
subjects using the drug eluting peripheral vascular stent system
subjects using the Nitinol Stent System (Cordis Corporation)
Outcomes
Primary Outcome Measures
primary patency rate at 12 months after operation
the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively
Secondary Outcome Measures
primary patency rate at 6 months after operation
the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 6 months postoperatively
target lesion revascularization rate
subject found that the presence of restenosis in the target lesion in follow-up , and need to re-intervention or bypass graft according to the clinical symptoms
Stent fracture rate
using the Dual Fluoroscopic Imaging
Full Information
NCT ID
NCT03121430
First Posted
April 9, 2017
Last Updated
February 14, 2019
Sponsor
Zhejiang Zylox Medical Device Co., Ltd.
Collaborators
Guangzhou Osmunda Medical Device Technology, Inc., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03121430
Brief Title
Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
Official Title
The Safety and Efficacy of Drug Eluting Peripheral Vascular Stent System for the Treatment of Superficial Femoral Artery Stenosis and /or Occlusion: a Multi-center Stratified Randomized Single- Blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Zylox Medical Device Co., Ltd.
Collaborators
Guangzhou Osmunda Medical Device Technology, Inc., Ltd.
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
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.
Detailed Description
This is a prospective, multicenter, randomized study designed to enroll 138 patients with superficial femoral artery stenosis and /or occlusion who will be randomized 1:1 to be treated with the Drug eluting peripheral vascular stent system versus the commercially available Nitinol Stent System (Cordis Corporation). Patients will receive Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging at 6th month and 12th month post procedure. Clinical visits are scheduled at 0~30 days, 6 months, 12 months, and telephone visits are scheduled at 1 month, 3months, and 9 months. Furthermore, CDU will also be performed at baseline in all participants of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion
Keywords
peripheral arterial disease, Drug eluting peripheral vascular stent system, primary patency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
subjects using the drug eluting peripheral vascular stent system
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
subjects using the Nitinol Stent System (Cordis Corporation)
Intervention Type
Device
Intervention Name(s)
Drug eluting peripheral vascular stent system
Intervention Description
Drug eluting peripheral vascular stent system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Intervention Type
Device
Intervention Name(s)
Nitinol Stent System
Other Intervention Name(s)
Cordis Corporation
Intervention Description
Nitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Primary Outcome Measure Information:
Title
primary patency rate at 12 months after operation
Description
the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively
Time Frame
12 months
Secondary Outcome Measure Information:
Title
primary patency rate at 6 months after operation
Description
the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 6 months postoperatively
Time Frame
6 months
Title
target lesion revascularization rate
Description
subject found that the presence of restenosis in the target lesion in follow-up , and need to re-intervention or bypass graft according to the clinical symptoms
Time Frame
Preoperative，up to 1 month，6 months，12 months
Title
Stent fracture rate
Description
using the Dual Fluoroscopic Imaging
Time Frame
6 months、12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria in Preoperative:
Aged from 18 to 85 years old, male or female
Subject's target lesions were stenosis and/or occlusion
Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent
Exclusion Criteria in Preoperative:
In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration
Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration
Subject with coagulation abnormalities should not be performed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gao Feng
Phone
+86 (0)10 8220-7036
Ext
823
Email
md@osmundacn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Jie
Phone
13819565660
Email
jie.liang@zyloxmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Zhong
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guo Wei
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
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