Stent Complication, Vascular Diseases
Conditions
Brief 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.
Interventions
DEVICEEluvia drug eluting stent
Eluvia drug eluting stent for peripheral arterial disease
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| F-TLR | 24 months | free of target vascular reconstruction |
| limb salvage rate | 24 months | Proportion of patients without ambutation |
| The change of Rutherfor classification | 24 months | Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the life quality change | 24 months | Amount by Vas-Qol questionare between perioperation and 24month postoperation |
| Technical success rate | 1 month | Percentage of patients with successful endovascular treatment without postoperative complications |
| Wound Healing Evaluation | 24 months | If there is an ulcer wound, evaluate the ulcer wound healing at 24 months after surgery and before treatment |
| Economics Evaluation | 24 months | Cumulative hospitalization expenses related to treatment within 24 months |
| the patency target lesion | 24 months | Restenosis was defined as PSVR \> 2.4 as determined by vascular ultrasonography |
| mortality rate | 24 months | the propotion of death |
Countries
China
Outcome results
None listed