Eluvia DES for the Patients With Femoropopliteal Artery Lesions.

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522218
• Other study ID #: IIT20220166B-X1
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Stent Complication
• Vascular Diseases

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