Eluvia DES for the Patients with Femoropopliteal Artery Lesions.
Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions
First Affiliated Hospital of Zhejiang University
400 participants
Aug 1, 2022
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Rutherford Stage 2-5.
- 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 Criteria5
- 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.
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Interventions
Eluvia drug eluting stent for peripheral arterial disease
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05522218