Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- limb salvage rate
Study Overview
Brief Summary
This study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with Eluvia stent. Each patient was followed up for 2 years. The technical success rate, target lesion patency rate, quality of life improvement, cost of Eluvia stent implantation, and other outcomes will be analysed.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Rutherford Stage 2-
- •At least 90% stenosis or occlusion of the femoropopliteal artery.
- •Eluvia stents are used for target lesions.
- •Agree and sign the informed consent form
Exclusion Criteria
- •Life expectancy is less than 1 year.
- •Those with severe infection and gangrene of the limbs or those with tissue defects beyond the plane of the toes (ie major tissue loss), who may undergo major amputation even if the blood vessels are opened.
- •Patients and their families are reluctant to join the observational study, or have difficulty in communication and are unable to assess the quality of life.
- •Patients with in-stent restenosis of the femoral popliteal artery.
- •Patients with acute arterial thrombosis.
Outcomes
Primary Outcomes
limb salvage rate
Time Frame: 24 months
Proportion of patients without ambutation
The change of Rutherfor classification
Time Frame: 24 months
Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months
F-TLR
Time Frame: 24 months
free of target vascular reconstruction
Secondary Outcomes
- mortality rate(24 months)
- Wound Healing Evaluation(24 months)
- the patency target lesion(24 months)
- Economics Evaluation(24 months)
- Technical success rate(1 month)
- the life quality change(24 months)
Investigators
Ziheng Wu, MD
Associated chief physician
First Affiliated Hospital of Zhejiang University