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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05522218
Other study ID # IIT20220166B-X1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date December 31, 2025

Study information

Verified date September 2023
Source First Affiliated Hospital of Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 31, 2025
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change of Rutherfor classification Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months 24 months
Primary F-TLR free of target vascular reconstruction 24 months
Primary limb salvage rate Proportion of patients without ambutation 24 months
Secondary Technical success rate Percentage of patients with successful endovascular treatment without postoperative complications 1 month
Secondary the patency target lesion Restenosis was defined as PSVR > 2.4 as determined by vascular ultrasonography 24 months
Secondary mortality rate the propotion of death 24 months
Secondary the life quality change Amount by Vas-Qol questionare between perioperation and 24month postoperation 24 months
Secondary the life quality change Amount by EQ-5D5L questionare between perioperation and 24month postoperation 24 months
Secondary Economics Evaluation Cumulative hospitalization expenses related to treatment within 24 months 24 months
Secondary Wound Healing Evaluation If there is an ulcer wound, evaluate the ulcer wound healing at 24 months after surgery and before treatment 24 months
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