Eluvia DES for the Patients With Femoropopliteal Artery Lesions.

Recruiting

• Conditions: Vascular Diseases; Stent Complication

• Registration Number: NCT05522218
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-28
• Study First Posted: 2022-08-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-08-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
limb salvage rate	24 months	Proportion of patients without ambutation
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China