AcoArt Ⅰ / SFA China

• drug eluting balloon catheter (trade name: Orchid) (Device), also known as drug eluting dilation catheter
• common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral) (Device), also known as common PTA catheter

Primary outcomes

• Late Lumen Loss [6 months]: measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months

Secondary outcomes

• Minimal lumen diameter (MLD) [6 months]: measure minimal lumen diameter (MLD) of target lesion
• Restenosis rate of target vessel [6 months, 12 months, 18 months, 24months]: stenosis over 50% is defined as restenosis
• target lesion revascularization [6 months, 12 months, 18 months, 24 months]: target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
• change in Rutherford stage [6 months, 12 months, 18 months, 24 months]: based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment Stage clinical symptom 0 asymptomatic 1. mild claudication 2. moderate claudication 3. severe claudication 4. ischemic rest pain 5. minor tissue loss 6. ulceration or gangrene
• change in ankle brachial index(ABI) [6 months]: change in ankle brachial index(ABI) compared to pretreatment
• major amputation [6 months, 12 months, 18 months, 24 months]: major amputation at the index limb(major amputation is defined as an amputation above the foot)
• Death [12 months, 18 months, 24 months]: death of any cause

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 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

• Results publication: Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3. PMID 42573020
• Results publication: Ren H, Liu J, Zhang J, Zhuang B, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W. Five-Year Outcomes of Post-Drug-Coated Balloon Angioplasty Dissection in Complex Femoropopliteal Artery Disease. Int J Gen Med. 2021 Aug 5;14:4197-4207. doi: 10.2147/IJGM.S316916. eCollection 2021. PMID 34385840
• Results publication: Sun G, Liu J, Jia S, Zhang J, Zhuang B, Jia X, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W; AcoArt I Trial Investigators. Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study. Vascular. 2021 Jun;29(3):340-349. doi: 10.1177/1708538120953663. Epub 2020 Sep 9. PMID 32903168