RecruitingNot Applicable

Eluvia DES for the Patients with Femoropopliteal Artery Lesions.

China400 participantsStarted 2022-08-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The change of Rutherfor classification

Timeframe: 24 months

F-TLR

Timeframe: 24 months

limb salvage rate

Timeframe: 24 months

Trial details

NCT IDNCT05522218

SponsorFirst Affiliated Hospital of Zhejiang University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Vascular Diseases trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 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.