AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China

PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.

DEBs are designed to promote arterial patency by reducing neointimal proliferation.

• drug eluting balloon catheter (trade name: Orchid) (Device): use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

Primary outcomes

• Primary patency of target lesion. [12 months]: The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of ≤2.4

Secondary outcomes

• target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion [6 months, 12 months]: target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
• improvment in Rutherford stage [6 months, 12 months]: improvementin Rutherford stage is defined as an upward shift of at least 1 category on Rutherford classification as compared to baseline
• change in ankle brachial index(ABI) [12 months]: change in ankle brachial index(ABI) compared to baseline
• Device success during the operation [during the operation]: Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Age between 18 and 80 years
* Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5
* an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery
* Total length of treat lesion(s)is less or equal to 20cm
* signed Patient informed consent form

Exclusion Criteria:

* plasma Cr level greater than 150 umol/L in patients
* patients with acute thrombosis requiring lysis or thrombectomy
* 2 or more than 2 stenosis lesions in traget vessel
* patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
* patient requiring intervention in both lower limbs at the same time
* have >30% residual stenosis or blood-limited dissection after predilation
* distal outflow through less than one lower leg vessel
* known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* patients participating in another clinical trials with interfere with this trial in the past 3 months
* pregnancy and lactating woman
* untreatable bleeding diatheses
* other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 1 years)
* patients unable or unwilling to participate this trial

• Wei Guo, Principal investigator, Chinese PLA General Hospital
• Yinghua Zou, Principal investigator, Peking University First Hospital