Actively Recruiting
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
Led by Zhejiang Zylox Medical Device Co., Ltd. · Updated on 2024-12-04
130
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.
CONDITIONS
Official Title
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 80 years, regardless of sex
- Diagnosed with atherosclerotic disease of the common iliac or external iliac artery
- Rutherford classification of 2 to 4 for the target limb
- Able to understand the study purpose, comply with the protocol, and sign informed consent
You will not qualify if you...
- Pregnant, planning pregnancy, or breastfeeding
- Previous vascular graft in the native iliac artery
- Stroke or myocardial infarction within 3 months before enrollment
- Uncorrectable bleeding disorders or severe coagulation abnormalities
- Serum creatinine 6 bcmol/L (2.5 mg/dL) or on dialysis
- ALT or AST 6 times the upper limit of normal
- Severe anemia (hemoglobin < 60.0 g/L)
- Allergic or intolerant to cobalt-based alloys, ePTFE, aspirin, clopidogrel, heparin, rivaroxaban, paclitaxel, contrast agents, or study materials
- Vascular intervention within 30 days before or planned within 30 days after surgery
- Intra-arterial thrombolysis in target vessel within 14 days before enrollment
- Significant organ dysfunction or severe conditions affecting compliance or life expectancy
- Currently in another clinical trial with investigational treatments
- Other conditions making the participant unsuitable per investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Medical Centre, Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
W
Wei Guo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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