Eluvia DES for the Patients With Femoropopliteal Artery Lesions.

Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of 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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Stent Complication
• Intervention / Treatment: Device: Eluvia drug eluting stent

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • First Affiliated Hospital of Zhejiang University
      • Contact: Ziheng Wu, PhD; Phone Number: 0571-87236745; Email: wuziheng@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

peripheral arterial disease patients implanted with Eluvia stent

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Percentage of patients with successful endovascular treatment without postoperative complications	1 month
the patency target lesion	Restenosis was defined as PSVR > 2.4 as determined by vascular ultrasonography	24 months
mortality rate	the propotion of death	24 months
the life quality change	Amount by Vas-Qol questionare between perioperation and 24month postoperation	24 months
the life quality change	Amount by EQ-5D5L questionare between perioperation and 24month postoperation	24 months
Economics Evaluation	Cumulative hospitalization expenses related to treatment within 24 months	24 months
Wound Healing Evaluation	If there is an ulcer wound, evaluate the ulcer wound healing at 24 months after surgery and before treatment	24 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 28, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: IIT20220166B-X1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After recruitment, data will be shared after 2 years of follow-up

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No