Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
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
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedStudy Start
First participant enrolled
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedFebruary 18, 2019
February 1, 2019
1.7 years
April 9, 2017
February 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 months
Secondary Outcomes (3)
primary patency rate at 6 months after operation
6 months
target lesion revascularization rate
Preoperative，up to 1 month，6 months，12 months
Stent fracture rate
6 months、12 months
Study Arms (2)
Group A
EXPERIMENTALsubjects using the drug eluting peripheral vascular stent system
Group B
ACTIVE COMPARATORsubjects using the Nitinol Stent System (Cordis Corporation)
Interventions
Drug eluting peripheral vascular stent system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Nitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital, Sichuan University
Chengdu, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chen Zhong
Beijing Anzhen Hospital
- PRINCIPAL INVESTIGATOR
Guo Wei
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2017
First Posted
April 20, 2017
Study Start
October 22, 2018
Primary Completion
July 1, 2020
Study Completion
February 1, 2021
Last Updated
February 18, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share