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Recruiting NCT05522218

Eluvia DES for the Patients with Femoropopliteal Artery Lesions.

— Observational Vascular Diseases Stent Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eluvia drug eluting stent.
Who it may be relevant to
Registry conditions: Vascular Diseases, Stent Complication. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions

Overview

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.

Interventions

  • Device Eluvia drug eluting stent
    Eluvia drug eluting stent for peripheral arterial disease

Primary outcome measures

  • The change of Rutherfor classification [Time frame: 24 months]
  • F-TLR [Time frame: 24 months]
  • limb salvage rate [Time frame: 24 months]
Secondary outcome measures (7)
  • Technical success rate [Time frame: 1 month]
  • the patency target lesion [Time frame: 24 months]
  • mortality rate [Time frame: 24 months]
  • the life quality change [Time frame: 24 months]
  • the life quality change [Time frame: 24 months]
  • Economics Evaluation [Time frame: 24 months]
  • Wound Healing Evaluation [Time frame: 24 months]

Eligibility criteria

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.
  • Patients with in-stent restenosis of the femoral popliteal artery.
  • Patients with acute arterial thrombosis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • First Affiliated Hospital of Zhejiang University — Hangzhou

Identifiers

NCT: NCT05522218 · IIT20220166B-X1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗