Symptomatic in situ or restenosis lesions proximal to the primary superficial femoral artery (SFA) and/or popliteal artery
Conditions
Interventions
Experimental group:Peripheral drug-eluting stents
Control group:Eluvia nitinol eluting vascular stent
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old= age = 80 years old, gender is not limited; 2. Clinical diagnosis of lower extremity arteriosclerosis occlusive disease; 3. Rutherford Rating 2-5; 4. Patients whose target lesions are suitable for stent implantation; 5. Patients whose target lesions are single or series lesions located in the superficial femoral artery and/or proximal popliteal artery (i.e. within the P1 segment) and meet one of the following criteria: a) 70%=lesion stenosis degree<100%, 20mm=total length of lesion=200mm; b) Completely occluded lesion, total length of the lesion =100mm; c) The total length of the combined lesion is =200mm, and the length of the occlusive segment is =100mm 6. The diameter of the target blood vessel = 4.0mm and = 6.0mm; 7. Patients with successful passage of the guidewire through the target lesion site; 8. Patients with ipsilateral iliac artery inflow tract patency (vascular stenosis =50%) or ipsilateral iliac artery inflow tract lesion that has been successfully managed (i.e., residual stenosis =30% after treatment); 9. The patient must have at least one autologous subpopular artery in the affected foot unobstructed before surgery (the degree of stenosis of the blood vessel is =50%). 10. The patient or his/her guardian can understand the purpose of the trial, voluntarily participate and sign a written informed consent form,patients who can be followed up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females; 2. Patients with non-atherosclerotic lesions (e.g., Buerger's disease, vasculitis); 3. Patients who have had or plan to have a major amputation; 4. Patients with a life expectancy of less than 1 year; 5. Patients who have had stroke or myocardial infarction within 3 months before surgery or who currently have unstable angina; 6. Severe renal insufficiency, serum creatinine greater than 2 times the upper limit of normal; 7. Patients with acute embolization or thrombosis requiring thrombolysis or thrombectomy; 8. Known allergy or intolerance to paclitaxel, contrast agents, or antiplatelet agents, etc.; 9. Patients with severe coagulation abnormalities or uncontrolled severe infections who are not suitable for endovascular surgery; 10. Vascular access infection or systemic active infection; 11. Patients whose target lesion is restenosis after vascular stent or bypass surgery; 12. Patients who have been treated with a drug balloon for target lesions within 6 months prior to surgery; 13. Patients with aneurysms within the target vessels; 14. The patient is participating in clinical trials of other drugs or medical devices at the time of screening,and has not yet completed the study's primary endpoint; 15. Patients with severe residual stenosis after the target lesion was fully pre-dilatated by the balloon, that is, 30% of the residual stenosis >; 16. The target lesion is dilated with a pre-dilated balloon, and the balloon cannot be fully expanded; 17. Patients whose target lesions require adjuvant treatment using volume reduction techniques (such as atherectomy, laser therapy, etc.); 18. Patients on dialysis (including peritoneal dialysis and hemodialysis); 19. The investigator believes that the patient may not be able to follow the trial protocol,or there are other circumstances that make it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate of target lesion at 12 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;success rate of operation;Primary patency rate of target lesions at 6 months and 2-5 years postoperatively;Secondary patency rate of target lesion at 6 months, 12 months, and 2-5 years postoperatively;Change in Rutherford grade at 1 month, 6 months, 12 months, and 2-5 years postoperatively;Change in Ankle Brachial Index (ABI) at 6 months, 12 months, and 2 to 5 years postoperatively;Incidence of major adverse events (MAE)at 1 month, 6 months, 12 months, 2-5 years postoperatively;Incidence of target lesion revascularization at 1 month, 6 months, 12 months, 2-5 years postoperatively;Incidence of clinically symptom-driven target lesion revascularization (CD-TLR) at 1 month, 6 months, 12 months, 2-5 years postoperatively;Incidence of all-cause mortality at 1 month, 6 months, 12 months, 2-5 years postoperatively;Incidence of major amputation at 1 month, 6 months, 12 months, 2-5 years postoperatively;Incidence of small amputation at 1 month, 6 months, 12 months, 2-5 years postoperatively;Incidence of stent rupture at 12 months postoperatively; | — |
Countries
China
Contacts
Public ContactDai Xiangchen
Tianjin Medical University General Hospital
Outcome results
None listed