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
This trial does not accept healthy volunteersQualifiers
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 population
peripheral arterial disease patients implanted with Eluvia stent
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Eluvia drug eluting stent
DeviceEluvia drug eluting stent for peripheral arterial disease
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The change of Rutherfor classification
Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months
Time frame
24 months2
F-TLR
free of target vascular reconstruction
Time frame
24 months3
limb salvage rate
Proportion of patients without ambutation
Time frame
24 monthsSecondary outcomes
1
Technical success rate
Percentage of patients with successful endovascular treatment without postoperative complications
Time frame
1 month2
the patency target lesion
Restenosis was defined as PSVR \> 2.4 as determined by vascular ultrasonography
Time frame
24 months3
mortality rate
the propotion of death
Time frame
24 months4
the life quality change
Amount by Vas-Qol questionare between perioperation and 24month postoperation
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov