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NCT Number: NCT05522218

Eluvia DES for the Patients with Femoropopliteal Artery Lesions.

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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Key information

Conditions

Vascular Diseases Cardiovascular Diseases Stent Complication

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Ziheng Wu, PhD

CONTACT

[email protected]

0571-87236745

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eluvia drug eluting stent

Device

Eluvia drug eluting stent for peripheral arterial disease

Primary outcomes

  1. The change of Rutherfor classification

    Time frame: 24 months

    Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months

  2. F-TLR

    Time frame: 24 months

    free of target vascular reconstruction

  3. limb salvage rate

    Time frame: 24 months

    Proportion of patients without ambutation

Secondary outcomes

  1. Technical success rate

    Time frame: 1 month

    Percentage of patients with successful endovascular treatment without postoperative complications

  2. the patency target lesion

    Time frame: 24 months

    Restenosis was defined as PSVR > 2.4 as determined by vascular ultrasonography

  3. mortality rate

    Time frame: 24 months

    the propotion of death

  4. the life quality change

    Time frame: 24 months

    Amount by Vas-Qol questionare between perioperation and 24month postoperation

  5. the life quality change

    Time frame: 24 months

    Amount by EQ-5D5L questionare between perioperation and 24month postoperation

  6. Economics Evaluation

    Time frame: 24 months

    Cumulative hospitalization expenses related to treatment within 24 months

  7. Wound Healing Evaluation

    Time frame: 24 months

    If there is an ulcer wound, evaluate the ulcer wound healing at 24 months after surgery and before treatment

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2022
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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