{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T05:18:36Z","timestamp":1788585516493,"version":"build-2803163510"},"reference-count":26,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2023,3,15]],"date-time":"2023-03-15T00:00:00Z","timestamp":1678838400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Intact Vascular, Inc"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Vascular"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The TOBA (Tack Optimized Balloon Angioplasty) II trial is a prospective, single-arm, multicenter study that investigated Tack treatment for patients with dissection after angioplasty in the superficial femoral artery and\/or proximal popliteal artery. The Tack device is a nitinol-based, short (6\u00a0mm), stent-like implant with low outward force that can be deployed in a targeted fashion to treat vascular dissection. TOBA II primary results through 12 months have been published previously. This report provides follow-up safety and efficacy results through 24 months (RC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The TOBA II trial enrolled 213 patients with Rutherford classification 2 to 4 and a de novo or non-stented restenotic lesion in the superficial femoral artery and\/or proximal popliteal artery who developed a dissection of any grade after treatment with plain balloon or drug-coated balloon (DCB) angioplasty. Participants were followed for 30 days, 6 months, 12 months, 24 months, and 36 months following the procedure. Evaluations included clinically driven target lesion revascularization (CD-TLR), ankle-brachial index, Rutherford classification, peripheral artery questionnaire, quality of life assessed by the EQ-5D-3L, and the Walking Impairment Questionnaire.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At enrollment, mean age was 68.2 \u00b1 9.1 years, 70.9% were male, and 95.8% of patients were categorized as RC 2 or 3. The distribution of balloon types in the study were standard balloons: 42.3%; and drug-coated balloons: 57.7%. At 24-month follow-up, 167 patients (78.4%) had available data. The overall survival rate at 24 months was 95.4% and there were no major amputations during this time. After 24 months of follow-up, the Kaplan\u2013Meier freedom from CD-TLR was 77.7%. Rutherford classification, ankle-brachial index, and quality of life were significantly improved compared with baseline through 24 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The TOBA II 24-month data demonstrate durable intermediate-term outcomes with the use of the Tack Endovascular System. Tack deployment was a safe and effective therapeutic option for dissection repair following angioplasty.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17085381231162128","type":"journal-article","created":{"date-parts":[[2023,3,15]],"date-time":"2023-03-15T04:58:29Z","timestamp":1678856309000},"page":"850-857","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Treating post-angioplasty dissection in the femoropopliteal arteries using the tack endovascular system: Tack optimized balloon angioplasty II 24-month results"],"prefix":"10.1177","volume":"32","author":[{"given":"Marianne","family":"Brodmann","sequence":"first","affiliation":[{"name":"Medical University of Graz"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Werner","sequence":"additional","affiliation":[{"name":"Hanusch Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ami","family":"Sood","sequence":"additional","affiliation":[{"name":"Philips North America LLC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4676-2839","authenticated-orcid":false,"given":"William A","family":"Gray","sequence":"additional","affiliation":[{"name":"Lankenau Heart Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,3,15]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.109.903468"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2016.11.007"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1177\/1358863X07079823"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2014.07.032"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1177\/1526602817698634"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1583\/13-4392R.1"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2004.11.026"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.22124"},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051303"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.107.689141"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1583\/08-2676.1"},{"key":"e_1_3_5_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2016.02.043"},{"key":"e_1_3_5_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2019.08.005"},{"key":"e_1_3_5_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2020.01.078"},{"key":"e_1_3_5_16_2","doi-asserted-by":"publisher","DOI":"10.1177\/15266028221083462"},{"key":"e_1_3_5_17_2","first-page":"6","volume-title":"Manual of operations, NHLBI PTCA Registry","author":"National, Heart, Lung, and Blood Institute","year":"1985","unstructured":"National, Heart, Lung, and Blood Institute. 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