Actively Recruiting
Study Evaluating the Peripheral Balloon-Expandable Covered Stent System for Treating Narrowing or Blockage in the Common and External Iliac Arteries
Led by Zhejiang Zylox Medical Device Co., Ltd. · Updated on 2024-12-04
130
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Peripheral Balloon-Expandable Covered Stent System for treating narrowing or blockage (stenosis or occlusion) in the common and external iliac arteries, which are major blood vessels in the pelvis. This multi-center, prospective, single-arm clinical trial aims to assess the safety and effectiveness of this stent system by comparing results to pre-set performance goals. Participants include adults aged 18 to 80 years diagnosed with this vascular condition. The study involves implanting the balloon-expandable, covered stent into the affected iliac arteries to open the blood flow. After the procedure, participants will have follow-up visits at hospital discharge and then at 1, 6, 12, 24, and 36 months to monitor the stent's function and safety. The trial does not include a comparison group and focuses on this single treatment method throughout the study period. During the follow-up visits, researchers will assess primary patency at 12 months, which measures whether the stent remains open, and will monitor for major adverse events over 36 months. Secondary patency will also be checked at 6, 12, 24, and 36 months. Participants will undergo clinical evaluations to track outcomes and any complications related to the stent system. The total participation lasts up to three years after the initial procedure.
CONDITIONS
Brief 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 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 heart attack within 3 months before enrollment
- Known bleeding disorders or severe coagulation abnormalities
- Serum creatinine ≥ 221 µmol/L or on dialysis
- Elevated liver enzymes (ALT or AST ≥ 2 times upper limit)
- Severe anemia (hemoglobin < 60.0 g/L)
- Allergic or intolerant to cobalt 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 drugs, biologics, or devices
- Other conditions making participation unsuitable per investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo implantation of the Peripheral Balloon-Expandable Covered Stent System into the common and/or external iliac arteries to treat arterial blockages.
1 visit (in-person)
Duration - Up to 36 months
Participants are monitored for safety and effectiveness of the stent system with scheduled visits after the procedure.
Visits at discharge, and at 1, 6, 12, 24, and 36 months post-procedure
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
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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