{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:53:59Z","timestamp":1787018039906,"version":"build-2736575974"},"reference-count":21,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"6","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>A novel bioresorbable scaffold, the sirolimus-eluting Fantom, incorporates a radiopaque polymer, struts with a thickness of 125 \u00b5m, and a crossing profile of 1.35 mm. The purpose of this study was to evaluate the 9-month angiographic and 12-month clinical outcomes of the FANTOM scaffold in a larger patient population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and Results:<\/jats:title>\n                    <jats:p>The FANTOM II study (Safety &amp; Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold \u2013 First Report on Initial 24 Month Outcomes) was a prospective, multicenter trial which enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm diameter and lesion length \u226420 mm. Major adverse cardiac events through 12-month follow-up were assessed. Angiographic follow-up was performed in consecutive patient cohorts at 6 months (n=117) and 9 months (n=123). Acute delivery success, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235\/240), 95.8% (230\/240), 99.1% (228\/230), and 99.6% (227\/228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25\u00b10.40 mm and 0.33\u00b10.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients, respectively. Major adverse cardiac events and target lesion failure through 12 months occurred in 4.2% of 240 patients; scaffold thrombosis developed in only one patient (0.4%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness performance at 12-month follow-up. Longer-term follow-up is ongoing to examine the late outcomes with this novel device.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      . Unique identifier: NCT02539966.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circinterventions.118.007283","type":"journal-article","created":{"date-parts":[[2019,6,10]],"date-time":"2019-06-10T05:00:28Z","timestamp":1560142828000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":27,"title":["Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold"],"prefix":"10.1161","volume":"12","author":[{"given":"Bernard","family":"Chevalier","sequence":"first","affiliation":[{"name":"Ramsay G\u00e9n\u00e9rale de Sant\u00e9, Institut Cardiovasculaire Paris Sud, Massy, France (B.C., M.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandre","family":"Abizaid","sequence":"additional","affiliation":[{"name":"Instituto Dante Pazzanese de Cardiologia (A.A.)."},{"name":"Hospital Albert Einstein Sao Paulo, Brazil (A.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Didier","family":"Carri\u00e9","sequence":"additional","affiliation":[{"name":"CHU Toulouse Rangueil, Toulouse, France (D.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norbert","family":"Frey","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Schleswig-Holstein, Kiel, Germany (N.F., M.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Lutz","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Schleswig-Holstein, Kiel, Germany (N.F., M.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joachim","family":"Weber-Albers","sequence":"additional","affiliation":[{"name":"St.- Johannes-Hospital, Dortmund, Germany (J.W.-A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darius","family":"Dudek","sequence":"additional","affiliation":[{"name":"Szpital Uniwersytecki w Krakowie, Poland (D.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shu-Chuan","family":"Weng","sequence":"additional","affiliation":[{"name":"Reva Medical, San Diego, CA (S.-C.W., J.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariama","family":"Akodad","sequence":"additional","affiliation":[{"name":"Ramsay G\u00e9n\u00e9rale de Sant\u00e9, Institut Cardiovasculaire Paris Sud, Massy, France (B.C., M.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Anderson","sequence":"additional","affiliation":[{"name":"Reva Medical, San Diego, CA (S.-C.W., J.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregg W.","family":"Stone","sequence":"additional","affiliation":[{"name":"Columbia University Medical Center \/ New York-Presbyterian Hospital (G.W.S.)."},{"name":"The Cardiovascular Research Foundation, New York, NY (G.W.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the FANTOM II Clinical Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2015.12.018"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2016.11.258"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.09.041"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.5339\/gcsp.2015.62"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.110.003210"},{"key":"e_1_3_2_7_2","first-page":"52","article-title":"Intracoronary stenting and angiographic results strut thickness effect on restenosis outcome (ISAR-STEREO) trial.","volume":"2","author":"Kastrati A","year":"2012","unstructured":"Kastrati, A, Mehilli, J, Dirschinger, J, Dotzer, F, Schuhlen, H, Neumann, F-J, Fleckenstein, M, Pfafferott, C, Seyfarth, M, Schomig, A. 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