Eluvia DES for the Patients with Femoropopliteal Artery Lesions.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vascular Diseases Stent Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Eluvia drug eluting stent

Eluvia drug eluting stent for peripheral arterial disease

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Rutherford Stage 2-5.
2. At least 90% stenosis or occlusion of the femoropopliteal artery.
3. Eluvia stents are used for target lesions.
4. Agree and sign the informed consent form

Exclusion Criteria

1. Life expectancy is less than 1 year.
2. 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.
3. 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.
4. Patients with in-stent restenosis of the femoral popliteal artery.
5. Patients with acute arterial thrombosis.

Eligible Sex

ALL

Accepts Healthy Volunteers

No