Eluvia DES for the Patients with Femoropopliteal Artery Lesions.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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.
Eligibility criteria
Qualifiers
Rutherford Stage 2-5.
At least 90% stenosis or occlusion of the femoropopliteal artery.
Eluvia stents are used for target lesions.
Agree and sign the informed consent form
Disqualifiers
Life expectancy is less than 1 year.
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.
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.
Patients with in-stent restenosis of the femoral popliteal artery.
Trial design
Treatments tested in this trial
- Eluvia drug eluting stent
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov