{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T15:45:48Z","timestamp":1787499948225,"version":"build-2736575974"},"reference-count":14,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,5,12]],"date-time":"2024-05-12T00:00:00Z","timestamp":1715472000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Stent implantation has become standard of care in older children and adults for treatment of branch pulmonary artery stenosis (BPAS) and coarctation aorta (CoAo). There are no stents approved or available for infants that have the potential to be dilated to adult diameters. The Minima stent was designed to fulfill this unmet need.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Multicenter, prospective, nonrandomized early feasibility study\u00a0evaluating safety and effectiveness of the Minima stent for treatment of BPAS and CoAo. Primary endpoints included: (1) successful deployment across lesion, (2) stenosis relief defined by an increase in angiographic diameter of &gt;50% and (3) freedom from stent explant, embolization or migration at 30 days and 6 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between 2\/2022 and 5\/2022, 10 pts underwent Minima stent implantation with a median age and weight of 9 months (4\u201343 months) and 7.6\u2009kg (5.1\u221216.9\u2009kg). Procedural success and predefined stenosis relief was achieved in all cases (CoAo [\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20094], BPAS [\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20096]). Adverse events occurred in 3 pts: transient diminished lower extremity pulse (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20092), distal stent on\u2010balloon displacement successfully managed in the catheterization suite (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20091). There were no deaths or major adverse events. All patients were free from stent explant and migration at 30 days and 6 months with no evidence for significant restenosis at latest follow\u2010up.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Implantation of the Renata Minima stent was safe and effective for the treatment of BPAS and CoAo in this small cohort of infants and young children during early follow\u2010up. Based on these early results, an expanded study with longer follow\u2010up is warranted.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ccd.31074","type":"journal-article","created":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T01:39:57Z","timestamp":1715564397000},"page":"61-70","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Results of the multicenter early feasibility study (EFS) of the Renata Minima stent as treatment for branch pulmonary artery stenosis and coarctation of aorta in infants"],"prefix":"10.1002","volume":"104","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-6766-181X","authenticated-orcid":false,"given":"Darren P.","family":"Berman","sequence":"first","affiliation":[{"name":"Heart Institute Children's Hospital Los Angeles Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7587-7518","authenticated-orcid":false,"given":"Brian","family":"Morray","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology Seattle Children's Hospital Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Sullivan","sequence":"additional","affiliation":[{"name":"Heart Institute Children's Hospital Los Angeles Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shabana","family":"Shahanavaz","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Heart Institute Cincinnati Children's Hospital University of Cincinnati College of Medicine Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2740-8842","authenticated-orcid":false,"given":"Evan M.","family":"Zahn","sequence":"additional","affiliation":[{"name":"Smidt Heart Institute and Guerin Children's Cedars Sinai Medical Center Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,5,12]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0b013e31821b1f10"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.08.053"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.iccl.2018.08.005"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ-20-0915"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/hrt.74.6.689"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.29706"},{"key":"e_1_2_10_8_1","unstructured":"Clinical Trials.govID. NCT05086016. 2021."},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00246-023-03180-3"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.26690"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.120.009399"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.21526"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00246-016-1466-8"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1017\/S1047951119001549"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.22694"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.31074","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T11:23:09Z","timestamp":1720783389000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.31074"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,12]]},"references-count":14,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,7]]}},"alternative-id":["10.1002\/ccd.31074"],"URL":"https:\/\/doi.org\/10.1002\/ccd.31074","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,12]]},"assertion":[{"value":"2024-01-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-29","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-12","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}