%0 Journal Article
%T IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug
%A Feng Wang
%A Jeffrey J. Popma
%A Michael R. Jaff
%A Pei Li
%A Stefanie Deckers
%A Wei Guo
%A Weiguo Fu
%A Weiliang Jiang
%A Yinghua Zou
%A Zhong Chen
%J Journal of Endovascular Therapy
%@ 1545-1550
%D 2019
%R 10.1177/1526602819852084
%X Purpose: To confirm the safety and effectiveness of the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for de novo and native artery restenotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery in Chinese subjects. Materials and Methods: IN.PACT SFA China (ClinicalTrials.gov identifier NCT02118532) was a single-arm, independently adjudicated, prospective, premarket study that enrolled 143 subjects (mean age 66.8¡À7.7 years; 107 men) at 15 centers. The predominant risk factors were hypertension (104, 72.7%) and diabetes mellitus (66, 46.2%). The majority of subjects were classified as Rutherford category 2 or 3 [69 (48.3%) and 55 (38.5%), respectively]; 19 (13.3%) subjects had critical limb ischemia (Rutherford category 4). The mean lesion length was 10.4¡À6.51 cm; more than half of the lesions (75, 52.4%) were chronic total occlusions. Calcification was found in 66 (46.2%) lesions. Outcomes at 12 months were compared with DCB safety and effectiveness performance goals derived from the literature. The 30-day primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion revascularization (CD-TLR). Results: The primary safety outcome was 99.3% at 30 days. Follow-up compliance at 12 months was 92.6%. Estimated 1-year primary patency using Kaplan-Meier analysis was 90.9% and freedom from CD-TLR was 97.1%. The rate of CD-TLR at 12 months was 2.9%. The Rutherford category status improved significantly (p<0.001) between baseline and 12 months. Conclusion: Results from IN.PACT SFA China demonstrated high rates of patency and low rates of CD-TLR in Chinese subjects through 12 months despite patient and lesion complexity. These data are consistent with the results of other IN.PACT DCB trials
%K angioplasty
%K claudication
%K endovascular treatment
%K femoropopliteal segment
%K drug-coated balloon
%K occlusion
%K patency
%K peripheral artery disease
%K popliteal artery
%K restenosis
%K safety
%K stenosis
%K superficial femoral artery
%K target lesion revascularization
%U https://journals.sagepub.com/doi/full/10.1177/1526602819852084