{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,3]],"date-time":"2026-05-03T22:47:05Z","timestamp":1777848425965,"version":"3.51.4"},"reference-count":12,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2021,11,20]],"date-time":"2021-11-20T00:00:00Z","timestamp":1637366400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Endovasc Ther"],"published-print":{"date-parts":[[2022,8]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>The purpose was to evaluate the safety and efficacy of the Serranator percutaneous transluminal angioplasty serration balloon catheter in patients with infrapopliteal peripheral artery disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods:<\/jats:title>\n                    <jats:p>A prospective, multicenter, single-arm feasibility study in 46 patients with claudication or chronic limb-threatening ischemia, Rutherford Clinical Category (RCC) 3 to 5, that required treatment of the infrapopliteal arteries above the tibiotalar joint. The primary efficacy outcome was device success\u2014successful insertion, balloon inflation and deflation, and removal of the device(s) with a final diameter stenosis of &lt;50%. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) through 30 day postprocedure. Other outcomes were change in RCC and ankle-brachial index, wound healing, and clinically-driven target lesion revascularization (CD-TLR). A subset of 9 patients were further evaluated by optical coherence tomography (OCT) or intravascular ultrasound (IVUS) for the presence of serrations in treated lesions. Patient follow-up occurred at 30 days and 6 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Forty-six patients received treatment with the Serranator device and 55 lesions were treated. Fifty-three lesions were deemed analyzable by the core lab with data and reported hereafter. Device success was 91.7% and freedom from MALE + POD through 30 days was 95.7%. Pretreatment stenosis of 82% was reduced to 21.8% and only 1 lesion (1.9%) required a bailout stent for a grade D dissection. The average maximum balloon inflation pressure was 6 atmospheres. Serrations were present in all treated lesions (n=10) in 9 patients imaged with OCT\/IVUS as reviewed by the core laboratory. The RCC score improved by 1 or more level in 70% of patients at 6 months with 42% having a score of 0. The 6 month freedom from CD-TLR was 97.7%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Serranator treatment of infrapopliteal lesions showed excellent lumen gain with minimal evidence of arterial injury and low 6 month CD-TLR. Imaging by IVUS and OCT showed serrations without significant dissection, supporting the device\u2019s proposed mechanism of action.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/15266028211059917","type":"journal-article","created":{"date-parts":[[2021,11,20]],"date-time":"2021-11-20T04:46:53Z","timestamp":1637383613000},"page":"586-593","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":10,"title":["Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study"],"prefix":"10.1177","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8170-4960","authenticated-orcid":false,"given":"Andrew","family":"Holden","sequence":"first","affiliation":[{"name":"Auckland City Hospital, Auckland, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2647-9876","authenticated-orcid":false,"given":"Michael","family":"Lichtenberg","sequence":"additional","affiliation":[{"name":"Klinikum Hochsauerland GmbH, Arnsberg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5359-0476","authenticated-orcid":false,"given":"Przemyslaw","family":"Nowakowski","sequence":"additional","affiliation":[{"name":"University of Technology, Katowice, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4355-7397","authenticated-orcid":false,"given":"Christian","family":"Wissgott","sequence":"additional","affiliation":[{"name":"Imland Klinik Rendsburg, Rendsburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klaus","family":"Hertting","sequence":"additional","affiliation":[{"name":"Krankenhaus Buchholz, Buchholz, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marianne","family":"Brodmann","sequence":"additional","affiliation":[{"name":"Division of Angiology, Medical University of Graz, Graz, Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2021,11,20]]},"reference":[{"key":"bibr1-15266028211059917","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2016.09.039"},{"key":"bibr2-15266028211059917","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2019.10.059"},{"issue":"8","key":"bibr3-15266028211059917","first-page":"205","volume":"31","author":"Mustapha JA","year":"2019","journal-title":"J Invasive Cardiol"},{"key":"bibr4-15266028211059917","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2015.07.011"},{"key":"bibr5-15266028211059917","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.113.001811"},{"key":"bibr6-15266028211059917","doi-asserted-by":"publisher","DOI":"10.1583\/JEVT-12-3815MR.1"},{"key":"bibr7-15266028211059917","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.06.1198"},{"key":"bibr8-15266028211059917","doi-asserted-by":"publisher","DOI":"10.2310\/6670.2009.00001"},{"key":"bibr9-15266028211059917","doi-asserted-by":"publisher","DOI":"10.1177\/1526602818820787"},{"key":"bibr10-15266028211059917","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.09.063"},{"key":"bibr11-15266028211059917","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1406235"},{"key":"bibr12-15266028211059917","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.028893"}],"container-title":["Journal of Endovascular Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/15266028211059917","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/15266028211059917","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/15266028211059917","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T21:34:17Z","timestamp":1777498457000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/15266028211059917"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,11,20]]},"references-count":12,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2022,8]]}},"alternative-id":["10.1177\/15266028211059917"],"URL":"https:\/\/doi.org\/10.1177\/15266028211059917","relation":{},"ISSN":["1526-6028","1545-1550"],"issn-type":[{"value":"1526-6028","type":"print"},{"value":"1545-1550","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,11,20]]}}}