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Patients underwent vessel preparation with retrievable scaffold therapy followed by sirolimus-coated balloon angioplasty. The primary safety outcome measure was a composite of all-cause mortality, major amputation, or clinically driven target lesion revascularization at 6 months. Secondary outcome measures included acute vessel recoil, perioperative death, angiographic late lumen loss between post-procedure and 6 months, as well as primary patency, major amputation, change in Rutherford class, and wound healing through 12 months.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>The study included 26 patients (mean age 71 years, 62% male, 88% Rutherford 5) with 28 treated infrapopliteal lesions (36% occluded, 54% TASC B\/C). Acute vessel recoil, measured in seven patients, was negligible (2.4 mm after treatment vs. 2.3 mm 15 minutes after deployment). A 6-month primary safety event occurred in 11.5% of patients (1 all-cause mortality, 1 major amputation, 1 clinically driven target lesion revascularization). Late lumen loss at 6 months was 0.7\u00b10.7 mm. At 12 months, primary patency was 89.5%, improvement in Rutherford class was observed in 68.2% of patients, 90% of patients were deemed very low\/low major limb amputation risk based on Wound, Ischemia, and foot Infection (WIfI) scores, and no additional major amputations or clinically driven target lesion revascularizations were reported.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Retrievable scaffold therapy combined with sirolimus-coated balloon angioplasty demonstrated promising safety and efficacy through 12 months in patients with infrapopliteal artery disease.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Level of Evidence IV<\/jats:title>\n            <jats:p>Case Series.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Graphical Abstract<\/jats:title>\n          <\/jats:sec>","DOI":"10.1007\/s00270-025-03987-y","type":"journal-article","created":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T18:11:08Z","timestamp":1740161468000},"page":"297-303","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Retrievable Scaffold Therapy Combined with Sirolimus-coated Balloon Angioplasty for Infrapopliteal Artery Disease: Final Results from the DEEPER LIMUS Trial"],"prefix":"10.1007","volume":"48","author":[{"given":"Leyla","family":"Schweiger","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katharina","family":"G\u00fctl","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Rief","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clemens","family":"Reiter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Janisch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ido","family":"Weinberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raghu","family":"Kolluri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1594-1885","authenticated-orcid":false,"given":"Larry E.","family":"Miller","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marianne","family":"Brodmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,2,21]]},"reference":[{"issue":"10100","key":"3987_CR1","first-page":"1211","volume":"390","author":"GBD Disease","year":"2016","unstructured":"Disease GBD, Injury I, Prevalence C. 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Schweiger reports no conflicts. K. G\u00fctl reports no conflicts. P. Rief reports no conflicts. C. Reiter reports no conflicts. M. Janisch reports no conflicts. I. Weinberg is the Medical Director for VasCore and consultant for Penumbra, Inc, Magneto Thrombectomy Solutions, and Daiichi Sankyo. R. Kolluri reports Consultant\/Advisor\/ DSMB\/ CEC - Abbott, Auxetics, Diachii Sankyo, Koya Medical, Medtronic, Penumbra, Philips, Surmodics, USA Therm, VB Devices; Board of Trustee -The VIVA Foundation (President), Intersocietal Accreditation Council | Vascular Testing, President Syntropic Core Lab. L. Miller reports consultancy with Micro Medical Solutions, Reflow Medical, and Shockwave Medical. M. Brodmann reports consultancy with Biotronik, Bolt Medical, Boston Scientific, Cook Medical, Cordis, Medtronic, R3 Vascular, and Reflow Medical.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was approved by the ethics committee of the Medical University of Graz (Graz, Austria).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"Consent for publication was obtained for every individual person\u2019s data included in the study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}