{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T09:35:02Z","timestamp":1777023302289,"version":"3.51.4"},"reference-count":23,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,11,11]],"date-time":"2019-11-11T00:00:00Z","timestamp":1573430400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>The SCAFFOLD trial evaluated the GORE\u00ae Carotid Stent (GCS), a novel, mesh\u2010covered device and evaluated outcomes at 1 year.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>SCAFFOLD was a prospective, multicenter, single\u2010arm clinical trial in patients with severe carotid artery stenosis (angiographically defined as symptomatic \u226550% or asymptomatic \u226580%) at increased risk for adverse events from carotid endarterectomy. Interim 30\u2010day analysis demonstrated low rates of death\/stroke\/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The rate of DSMI within 30\u2009days plus ipsilateral stroke between 31\u2009days and 1 year (primary endpoint) was compared to a predetermined performance goal. Secondary outcomes of freedom from clinically driven target lesion revascularization (CD\u2010TLR; diameter stenosis \u226580% by core lab angiography, or \u226550% with clinical symptoms) and restenosis (\u226580% diameter stenosis by core lab angiography) are reported as Kaplan\u2013Meier (KM) estimates.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 312 patients enrolled and treated, 264 were eligible per protocol and evaluable for major adverse events at 30\u2009days, and 244 (92%) of these were evaluable at 1 year. The proportion of patients with DSMI at 1 year was 4.5% and was significantly lower than the prespecified performance goal of 16.9% (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.00001). The proportion with ipsilateral stroke from 31 to 365\u2009days was 1.2%. The KM estimates of 1\u2010year event probability were 1.6% for CD\u2010TLR and 1.2% for restenosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Use of the mesh\u2010covered GCS in the SCAFFOLD trial demonstrated 100% technical success and low rates of both periprocedural and late stroke, with durable patency at 1 year.<\/jats:p><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link> Identifier: NCT01901874 (redacted).<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.28586","type":"journal-article","created":{"date-parts":[[2019,11,12]],"date-time":"2019-11-12T06:48:26Z","timestamp":1573541306000},"page":"121-127","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Evaluation of a novel mesh\u2010covered stent for treatment of carotid stenosis in patients at high risk for endarterectomy: 1\u2010year results of the SCAFFOLD trial"],"prefix":"10.1002","volume":"96","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4676-2839","authenticated-orcid":false,"given":"William A.","family":"Gray","sequence":"first","affiliation":[{"name":"Lankenau Heart Institute, Main Line Health  Wynnewood Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elad","family":"Levy","sequence":"additional","affiliation":[{"name":"Jacobs School of Medicine and Biomedical Sciences SUNY University at Buffalo &amp; Kaleida Health  Buffalo New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. Michael","family":"Bacharach","sequence":"additional","affiliation":[{"name":"North Central Heart Institute  Sioux Falls South Dakota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David Christopher","family":"Metzger","sequence":"additional","affiliation":[{"name":"Wellmont CVA Heart and Vascular Institute  Kingsport Tennessee"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bryan","family":"Randall","sequence":"additional","affiliation":[{"name":"W.L. Gore &amp; Associates, Inc.  Flagstaff Arizona"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adnan","family":"Siddiqui","sequence":"additional","affiliation":[{"name":"Jacobs Institute SUNY University at Buffalo &amp; Kaleida Health  Buffalo New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudio","family":"Schonholz","sequence":"additional","affiliation":[{"name":"Division of Vascular &amp; Interventional Radiology Medical University of South Carolina  Charleston South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Firas","family":"Alani","sequence":"additional","affiliation":[{"name":"Covenant Healthcare System  Saginaw Michigan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter A.","family":"Schneider","sequence":"additional","affiliation":[{"name":"Hawaii Permanente Medical Group and Kaiser Foundation Hospital  Honolulu Hawaii"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,11,11]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0912321"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.110.610212"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1515706"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.25283"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2015.04.460"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2017.01.029"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2015.04.016"},{"key":"e_1_2_9_9_1","unstructured":"Contego Medical LLC.http:\/\/contegomedical.com\/company\/. 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