Actively Recruiting
Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-09-27
400
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, prospective observational study involving 400 patients who have peripheral arterial disease affecting the femoral-popliteal artery segment. The study focuses on patients who have been implanted with the Eluvia drug-eluting stent. The goal is to analyze various outcomes including the technical success of the stent placement, how well the treated artery remains open (patency), improvements in patients' quality of life, and the economic impact of using the Eluvia stent. Participants receive the Eluvia drug-eluting stent as part of their treatment for severe narrowing or blockage of the femoral-popliteal artery. The study does not involve additional experimental treatments but observes patients who have undergone this specific stent implantation. Each patient is followed for two years after their procedure to collect data on the stent's performance and related health factors. During the two-year follow-up, researchers monitor changes in Rutherford classification (which assesses the severity of peripheral arterial disease), the need for re-intervention on the treated lesion, and limb salvage rates. They also evaluate technical success one month after stent placement, target lesion patency, mortality rates, quality of life changes, wound healing progress, and the economic aspects of the treatment. This comprehensive monitoring helps understand the overall impact of the Eluvia stent on patients' vascular health and lives.
CONDITIONS
Brief Title
Eluvia DES for the Patients with Femoropopliteal Artery Lesions.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rutherford Stage 2 to 5 peripheral arterial disease
- At least 90% narrowing or blockage of the femoropopliteal artery
- Treatment of target lesions with Eluvia drug-eluting stent
- Agreement to participate and signing of informed consent form
You will not qualify if you...
- Life expectancy less than 1 year
- Severe limb infection, gangrene, or major tissue loss beyond the toes
- Reluctance to participate or inability to communicate and assess quality of life
- In-stent restenosis of the femoral popliteal artery
- Acute arterial thrombosis
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 - 1 month
Participants receive the Eluvia drug-eluting stent for treatment of femoropopliteal artery lesions.
1 procedure visit and 1 follow-up visit
Duration - 24 months
Participants are monitored for clinical effectiveness, limb salvage, and quality of life over 24 months following stent implantation.
Periodic visits up to 24 months
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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