Eluvia DES for the Patients with Femoropopliteal Artery Lesions.

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Aug 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special stent called the Eluvia stent in patients with blockages in the femoral-popliteal artery, which is a major blood vessel in the leg. The goal is to see how well this stent works in improving blood flow and overall quality of life for patients suffering from peripheral arterial disease. The trial plans to include 400 patients, and each participant will be monitored for 2 years to track success rates and other important outcomes.

To be eligible for this study, patients should have a specific type of arterial blockage (at least 90% narrowing or a complete blockage) and must be at a certain level of disease severity. Participants will need to agree to be part of the study and provide informed consent. Throughout the trial, researchers will evaluate how well the stent works and its costs, ensuring that patients can expect to receive support and follow-up care during this time. This study is currently recruiting patients of all ages and genders, aiming to gather valuable information that could benefit future treatments for vascular diseases.

Gender

ALL

Eligibility criteria

• 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.