{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T10:49:57Z","timestamp":1788518997180,"version":"build-2803163510"},"reference-count":28,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2017,4,10]],"date-time":"2017-04-10T00:00:00Z","timestamp":1491782400000},"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":[[2017,6]]},"abstract":"<jats:p>Purpose: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)\u2013guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. Methods: The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2\u00b110.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53\u00b140 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis \u226450% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to \u226430% after Pantheris \u00b1 adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. Results: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%\u00b115.1% at baseline to 30.3%\u00b111.8% after Pantheris alone (p&lt;0.001) and to 22.4%\u00b19.9% after Pantheris \u00b1 adjunctive therapy (p&lt;0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82\u00b138 mm) achieved a similar significant reduction in stenosis to 35.5%\u00b113.6% after Pantheris alone (p&lt;0.001). Histological analysis of atherectomy specimens confirmed &lt;1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. Conclusion: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.<\/jats:p>","DOI":"10.1177\/1526602817701720","type":"journal-article","created":{"date-parts":[[2017,4,10]],"date-time":"2017-04-10T05:08:21Z","timestamp":1491800901000},"page":"355-366","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":57,"title":["Lower Extremity Revascularization Using Optical Coherence Tomography\u2013Guided Directional Atherectomy: Final Results of the E\n                    <u>V<\/u>\n                    aluat\n                    <u>I<\/u>\n                    on of the Pantheri\n                    <u>S<\/u>\n                    Opt\n                    <u>I<\/u>\n                    cal C\n                    <u>O<\/u>\n                    herence Tomography Imagi\n                    <u>N<\/u>\n                    g Atherectomy System for Use in the Peripheral Vasculature (VISION) Study"],"prefix":"10.1177","volume":"24","author":[{"given":"Arne G.","family":"Schwindt","sequence":"first","affiliation":[{"name":"Department of Vascular Surgery, St Franziskus-Hospital M\u00fcnster, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"J. Gray","family":"Bennett","sequence":"additional","affiliation":[{"name":"St Dominic-Jackson Memorial Hospital, Jackson, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William H.","family":"Crowder","sequence":"additional","affiliation":[{"name":"St Dominic-Jackson Memorial Hospital, Jackson, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suhail","family":"Dohad","sequence":"additional","affiliation":[{"name":"Cedars Sinai Medical Center, West Hollywood, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean F.","family":"Janzer","sequence":"additional","affiliation":[{"name":"Einstein Medical Center, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jon C.","family":"George","sequence":"additional","affiliation":[{"name":"Deborah Heart and Lung Center, Brown Mills, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barry","family":"Tedder","sequence":"additional","affiliation":[{"name":"St Bernards Medical Center, Jonesboro, AR, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas P.","family":"Davis","sequence":"additional","affiliation":[{"name":"St John Hospital and Medical Center, Detroit, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian M.","family":"Cawich","sequence":"additional","affiliation":[{"name":"Arkansas Heart Hospital, Little Rock, AR, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger S.","family":"Gammon","sequence":"additional","affiliation":[{"name":"Heart Hospital of Austin, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick E.","family":"Muck","sequence":"additional","affiliation":[{"name":"Good Samaritan Hospital, Cincinnati, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John 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J.","family":"Moulton","sequence":"additional","affiliation":[{"name":"University of Nebraska Medical Center, Omaha, NE, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramzan M.","family":"Zakir","sequence":"additional","affiliation":[{"name":"St Peters University Hospital, New Brunswick, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amir K.","family":"Kaki","sequence":"additional","affiliation":[{"name":"DMC Cardiovascular Institute Harper-Hutzel Hospital, Detroit, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary J.","family":"Fishbein","sequence":"additional","affiliation":[{"name":"Good Samaritan Hospital, Dayton, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huey B.","family":"McDaniel","sequence":"additional","affiliation":[{"name":"Coastal Vascular and Interventional, Pensacola, FL, 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