AcoArt Ⅰ / SFA China

Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)

The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.

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 40cm
• 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
• 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
• target lesion can't be cross by the guide wire
• 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 2 years)
• patients unable or unwilling to participate this trial