femoral and popliteal artery stenosis or occlusion
Conditions
Interventions
Test group:Drug-eluting vascular stent
Control group:Drug-coated balloon combined with self-expanding vascular stent
Sponsors
The First Affiliated Hospital , Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 18 years old = Age = 80 years old, gender unlimited; 2) Clinical diagnosis of lower limb arteriosclerosis obliterans; 3) Rutherford categories 2-5 ; 4) The patient or their guardian can understand the purpose of the trial, voluntarily participate and sign a written informed consent form, and can accept follow-up; 5) Patients with single or series lesions located in the superficial femoral artery and/or proximal popliteal artery (i.e. within P1 segment) that meet one of the following criteria: A) 70% = stenosis degree50%) or C-grade or above flow limiting dissection after pre dilation of the target lesion by naked balloon; 9) Patients with unobstructed ipsilateral iliac artery inflow (degree of vascular stenosis = 50%) or with ipsilateral iliac artery inflow lesions that have been successfully treated (i.e. residual stenosis = 30% after treatment); 10) Patients infrapopliteal and popliteal artery,i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot with on planned intervention.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; 2) Patients with non atherosclerotic lesions (such as Buerger's disease and vasculitis); 3) Patients who have undergone or plan to undergo major amputations; 4) Patients with severe renal failure (creatinine levels 2 times higher than the upper limit of normal); 5) Acute thrombotic or thrombotic patients with target lesions requiring thrombolysis or thrombectomy; 6) Patients with severe coagulation dysfunction or uncontrolled infection who are not suitable for intracavitary surgery; 7) Patients who are known to be allergic to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc; 8) Patients who have experienced stroke or myocardial infarction within 3 months before surgery or currently have unstable angina; 9) Patients with a life expectancy of less than 12 months; 10) The target lesion is patients with restenosis after vascular stent or bypass surgery treatment; 11) Patients with target lesions treated with drug balloon therapy within 6 months prior to surgery; 12) Patients with target lesions that require adjuvant treatment (such as circumcision, laser therapy, etc.); 13) Patients with aneurysms in the target vessel; 14) Patients with severe calcification of the target lesion (PACSS score: level 4); 15) The subjects are currently participating in clinical trials of other drugs or medical devices and have not yet completed the main research endpoint of the study; 16) The researchers believe that patients have poor compliance, are unable to follow the trial protocol, or there are other situations where they are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary patency rate (12 months); | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Procedural success rate;The incidence of major adverse events (including all-cause mortality, major amputation of the target limb, and target lesion revascularization) at 1 month, 6 months, 12 months, and 2-5 years;Primary patency rate at 6 months and 2-5 years;Assisted patency rates at 6 months, 12 months, and 2-5 years ;Secondary patency rates at 6 months, 12 months, and 2-5 years ;The incidence of TLR at 1 month, 6 months, 12 months, and 2-5 years ;The incidence of CD-TLR at 1 month, 6 months, 12 months, and 2-5 years ; All-cause mortality at 1 month, 6 months, 12 months, and 2-5 years ;Changes in Rutherford classification from basline at 1 month, 6 months, 12 months, and 2-5 years;Changes in ABI from basline at 6 months, 12 months, and 2-5 years;The incidence of major amputations at 1 month, 6 months, 12 months, and 2-5 years ;The incidence of minor amputations at 1 month, 6 months, 12 months, and 2-5 years ;The incidence of stent fracture at 12 months ; | — |
Countries
China
Contacts
Public ContactZhang Hongkun
The First Affiliated Hospital , Zhejiang University School of Medicine
Outcome results
None listed