This study aimed to report the outcomes of the IN.DEPT trial assessing the feasibility, preliminary safety data, and 12-month outcomes of a new drug-coated balloon product for peripheral artery disease (PAD) in Chinese patients.This is a prospective, multicenter. single-arm clinical trial. A total of 160 patients with superficial femoral artery (SFA) or/and proximal popliteal artery (PPA) lesions were treated with the new DCB. The preliminary efficacy endpoint was 12-month primary patency. The primary safety endpoint was freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinical-driven (CD) target lesion revascularization (TLR) within 12 months post-index procedure.One hundred and sixty patients presented with 162 target lesions. A total of 139 lesions (85.8%) were treated with one DCB, while the other 23 (14.2%) lesions were treated with two devices. The device success rate reached 100%. A total of 135 subjects reached the preliminary efficacy endpoint with a 12-month primary patency of 84.4%. There was no 30-day device- and procedure-related death or unplanned major target limb amputation at 12-month. Five CD-TLRs (3.1%) occurred during 12-month follow-up.Results from the IN. DEPT SFA trial showed satisfactory feasibility and safety of the new DCB through 12 months in Chinese PAD patients with femoropopliteal de novo lesions, including both stenosis and total occlusion types. Further comparative studies with larger scale and longer follow-up were warranted to verify the role of DCB in different types of PAD patients.Copyright © 2023. Published by Elsevier Inc.