机构：[1]Beijing Anzhen Hospital, Capital Medical University, Beijing, China首都医科大学附属安贞医院[2]Chinese PLA General Hospital, Beijing, China[3]The 2nd Affiliated Hospital of Harbin Medical University Hospital, Harbin, China[4]The First Affiliated Hospital of Dalian Medical University, Dalian, China大连医科大学附属第一医院[5]Zhongshan Hospital, Fudan University, Shanghai, China[6]Peking University First Hospital, Beijing, China[7]Medtronic, Bakken Research Center BV, Maastricht, the Netherlands[8]Medtronic, Plymouth, MN, USA[9]Beth Israel Deaconess Medical Center, Boston, MA, USA[10]Newton-Wellesley Hospital, Newton, MA, USA
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 +/- 7.7 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 +/- 6.51 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.
第一作者机构：[1]Beijing Anzhen Hospital, Capital Medical University, Beijing, China[*1]Beijing Anzhen Hospital, Capital Medical University, Building No. 2, Anzhen Road, Chaoyang District, Beijing, 100029 China.
共同第一作者：
通讯作者：
通讯机构：[1]Beijing Anzhen Hospital, Capital Medical University, Beijing, China[*1]Beijing Anzhen Hospital, Capital Medical University, Building No. 2, Anzhen Road, Chaoyang District, Beijing, 100029 China.
推荐引用方式(GB/T 7714)：
Chen Zhong,Guo Wei,Jiang Weiliang,et al.IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population[J].JOURNAL OF ENDOVASCULAR THERAPY.2019,26(4):471-478.doi:10.1177/1526602819852084.
APA：
Chen, Zhong,Guo, Wei,Jiang, Weiliang,Wang, Feng,Fu, Weiguo...&Jaff, Michael R..(2019).IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population.JOURNAL OF ENDOVASCULAR THERAPY,26,(4)
MLA：
Chen, Zhong,et al."IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population".JOURNAL OF ENDOVASCULAR THERAPY 26..4(2019):471-478
