{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T23:29:36Z","timestamp":1780356576490,"version":"3.54.1"},"reference-count":38,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2019,6,17]],"date-time":"2019-06-17T00:00:00Z","timestamp":1560729600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher","award":["Study sponsored by Medtronic."],"award-info":[{"award-number":["Study sponsored by Medtronic."]}],"id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Endovasc Ther"],"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:p>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\u00b17.7 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\u00b16.51 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&lt;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.<\/jats:p>","DOI":"10.1177\/1526602819852084","type":"journal-article","created":{"date-parts":[[2019,6,17]],"date-time":"2019-06-17T06:33:47Z","timestamp":1560753227000},"page":"471-478","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":19,"title":["IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population"],"prefix":"10.1177","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4795-5499","authenticated-orcid":false,"given":"Zhong","family":"Chen","sequence":"first","affiliation":[{"name":"Beijing Anzhen Hospital, Capital Medical University, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Guo","sequence":"additional","affiliation":[{"name":"Chinese PLA General Hospital, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weiliang","family":"Jiang","sequence":"additional","affiliation":[{"name":"The 2nd Affiliated Hospital of Harbin Medical University Hospital, Harbin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Wang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Dalian Medical University, Dalian, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weiguo","family":"Fu","sequence":"additional","affiliation":[{"name":"Zhongshan Hospital, Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yinghua","family":"Zou","sequence":"additional","affiliation":[{"name":"Peking University First Hospital, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefanie","family":"Deckers","sequence":"additional","affiliation":[{"name":"Medtronic, Bakken Research Center BV, 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