{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T03:15:04Z","timestamp":1793330104778,"version":"4.5.0"},"reference-count":21,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2021,12,15]],"date-time":"2021-12-15T00:00:00Z","timestamp":1639526400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100030895","name":"Concept Medical Inc.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100030895","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Endovasc Ther"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction:<\/jats:title>\n                    <jats:p>Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty (PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Material and Methods:<\/jats:title>\n                    <jats:p>Xtreme Touch-Neo [MagicTouch PTA] Sirolimus Coated Balloon (XTOSI) pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAOD. Primary endpoint was defined as primary patency at 6 months (duplex ultrasound peak systolic velocity ratio \u22642.4). Secondary endpoints included clinically driven target lesion revascularization (CD-TLR), amputation free survival (AFS), all-cause mortality, and limb salvage success.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Fifty patients were recruited. The mean age was 67 (n=31 [62%] males). SCB was applied to femoropopliteal in 20 patients (40%) and BTK in 30 patients (60%). Majority of treatments (94%) were performed for limb salvage indications (Rutherford scores 5 or 6). This was a high risk cohort, in which 90% had diabetes, 36% had coronary artery disease, 20% had end stage renal failure, and American Society of Anaesthesiologists (ASA) score was 3 or more in 80%. Mean lesion length treated was 227\u00b181 mm, of which 36% were total occlusions. Technical and device success were both 100%. At 30 days, mortality was 2% and major limb amputation was also 2%. Six-month primary patency was 80% (88.2% for femoropopliteal; 74% for BTK). At 12 months, freedom from CD-TLR was 89.7% (94.1% for femoropopliteal; 86.3% for BTK), AFS was 81.6% (90.0% for femoropopliteal; 75.9% for BTK), all-cause mortality was 14.3% (10.0% for femoropopliteal; 17.2% for BTK), and limb salvage success was 92.9% (94.4% for femoropopliteal; 91.7% for BTK). There was a statistically significant increase between baseline and 6-month toe pressures for both femoropopliteal (57.3\u00b123.3 mm Hg vs 82.5\u00b137.8 mm Hg; p&lt;.001) and BTK lesions (52.8\u00b119.2 mm Hg vs 70.7\u00b137 mm Hg; p&lt;.037). At 12 months, wound healing rate was 33\/39 (84.6%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>MagicTouch PTA SCB in the XTOSI study showed promising 6-month primary patency and encouraging 12-month freedom from CD-TLR, AFS, and limb salvage rates. No early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCB for treatment of PAOD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/15266028211064816","type":"journal-article","created":{"date-parts":[[2021,12,16]],"date-time":"2021-12-16T02:13:35Z","timestamp":1639620815000},"page":"780-789","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":36,"title":["MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months"],"prefix":"10.1177","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0752-503X","authenticated-orcid":false,"given":"Edward","family":"Choke","sequence":"first","affiliation":[{"name":"Sengkang General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tjun Yip","family":"Tang","sequence":"additional","affiliation":[{"name":"Sengkang General Hospital, Singapore"},{"name":"Singapore General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eilane","family":"Peh","sequence":"additional","affiliation":[{"name":"Sengkang General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karthikeyan","family":"Damodharan","sequence":"additional","affiliation":[{"name":"Sengkang General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shin Chuen","family":"Cheng","sequence":"additional","affiliation":[{"name":"Sengkang General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0865-467X","authenticated-orcid":false,"given":"Jia Sheng","family":"Tay","sequence":"additional","affiliation":[{"name":"Sengkang General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aloke V.","family":"Finn","sequence":"additional","affiliation":[{"name":"CVPath Institute Inc., Gaithersburg, MD, USA"},{"name":"University of Maryland School of Medicine, Baltimore, MD, 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