RecruitingNCT05522218

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


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

400 participants

Start Date

Aug 1, 2022

Study Type

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

Plain Language Summary

Simplified for easier understanding

This study is tracking outcomes in patients with blocked arteries in the upper leg (femoropopliteal artery) who are treated with the Eluvia drug-eluting stent — a special stent that slowly releases medication to keep the artery open. Researchers want to see how well patients do after this procedure over time. You may be eligible if: - You have peripheral artery disease (Rutherford Stage 2 to 5) - You have at least 90% blockage or complete occlusion of the femoropopliteal artery - The Eluvia stent is being used to treat your blockage - You agree to participate and sign the informed consent form You may NOT be eligible if: - Your life expectancy is less than 1 year - You have severe infection, gangrene, or tissue loss beyond the toes that may require major amputation regardless of treatment - You or your family are unwilling to join the study or have difficulty communicating for quality of life assessment - You have in-stent restenosis (re-blockage inside a prior stent) of the femoropopliteal artery - You have acute arterial blood clot (thrombosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEluvia drug eluting stent

Eluvia drug eluting stent for peripheral arterial disease


Locations(1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

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NCT05522218


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