Eluvia DES for the Patients with Femoropopliteal Artery Lesions.

Zhejiang University

Status: Enrolling

Conditions: Vascular Diseases; Stent Complication

Treatments: Device: Eluvia drug eluting stent

Study type: Observational

Funder types: Other

Identifiers

NCT05522218

IIT20220166B-X1

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.