AcoArt II.

Trial name or title	Prospective, Multi‐center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug‐Eluting Balloon in PTA Procedure of the Infrapopliteal Artery
Methods	Randomized controlled trial
Participants	Country: China Setting: single hospital Number of participants: 180 Inclusion criteria: Age 18 to 85 years PAD, with Rutherford classification between 4 and 6 An occlusion or a minimum grade of stenosis > 70% in the below‐PA vessels Expected survival time ≥ 1 year Signed participant informed consent form Exclusion criteria: Serum creatinine clearance rate < 30 mL/minute Acute thrombosis requiring lysis or thrombectomy Lysis or a lower limb intervention as a therapy within the last 6 weeks Requiring intervention in both lower limbs at the same time Instent restenosis in the blow‐knee PA Target lesion cannot be cross by the guidewire Stenosis rate of proximal outflow > 30% with or without intervention Length of the stenosis or occlusion in proximal outflow (including the Iliac artery, the SFA, the PA) > 150 mm before intervention Stenosis or occlusion of distal outflow for below‐the‐ankle artery Expected major amputations at the index limb before intervention Known hypersensitivity to acetylsalicylic acid (aspirin), heparin, clopidogrel, paclitaxel, or contrast medium Participating in another clinical trials with interfere with this trial in the same time Pregnancy and lactating women Untreatable bleeding diatheses
Interventions	Uncoated balloon angioplasty device: Lotus/Tulip catheter DEB device: Amphirion Deep catheter Vessels treated: below‐knee vessels
Outcomes	Primary: Late lumen loss Secondary: Device success rate Technical success rates Operation success rate TLR Major amputation Ulcer healing rate Change in Rutherford classification
Starting date	May 2014
Contact information	Qianqian Wei, weiqianqian@mrbc‐nccd.com
Notes	Sponsor: Acotec Scientific Company