Eluvia DES for the Patients with Femoropopliteal Artery Lesions.

NCT05522218 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Zhejiang University

Phase

Observational

Started

2022-08-01

Last updated

2024-09-27

Condition(s) studied

Vascular DiseasesStent Complication

Investigational drug(s) / intervention(s)

Eluvia drug eluting stent

Eluvia drug eluting stent: Eluvia drug eluting stent for peripheral arterial disease

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

The change of Rutherfor classification — 24 months
Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months
F-TLR — 24 months
free of target vascular reconstruction
limb salvage rate — 24 months
Proportion of patients without ambutation

Trial sites (1)

Facility	City	Region	Status
First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05522218 on ClinicalTrials.gov ↗ ← All trials in China