{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T17:30:37Z","timestamp":1790616637433,"version":"4.1.0"},"reference-count":13,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,5,7]],"date-time":"2025-05-07T00:00:00Z","timestamp":1746576000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,5,7]],"date-time":"2025-05-07T00:00:00Z","timestamp":1746576000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Vascular complications following large\u2010bore procedures may have a significant impact on patient morbidity and mortality, highlighting the critical need for an effective, safe, and reproducible closure device. We present our prospective multi\u2010center experience with a novel patch\u2010based closure device.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the safety and clinical performance of the PerQseal+ closure system in achieving hemostasis after femoral arterial large\u2010bore access with 14\u201322\u2009F sheaths.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The Frontier V study (NCT04799769) is a multicenter study that included patients undergoing an endovascular procedure requiring femoral access created by 14\u221222\u2009F sheaths. The primary safety outcome was major access site complications related to the PerQseal+. The primary efficacy outcome was the technical success rate of device deployment. Secondary outcomes included minor access site complications related to the device, time to hemostasia, time to deployment, and time to total closure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 88 subjects were included at seven investigational centers in Europe. One device\u2010related major access site complication (i.e., retroperitoneal hematoma) occurred (1.1%). The acute success rate of device deployment was 95%. There were five minor vascular access site complications directly related to the device (5.7%). The median time of device deployment was 5\u2009min, the median time to achieve hemostasia was 1\u2009min, and the median total closure time was 6\u2009min.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The PerQseal+ closure device was safe and effective for large\u2010bore arterial femoral closure. These results highlight its potential as a reliable alternative for large\u2010bore closure in endovascular procedures.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ccd.31574","type":"journal-article","created":{"date-parts":[[2025,5,8]],"date-time":"2025-05-08T02:34:56Z","timestamp":1746671696000},"page":"521-526","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["The Frontier V Study: Evaluating the Safety and Clinical Performance of a Large\u2010Bore Vascular Closure Device After Femoral Arterial Access"],"prefix":"10.1002","volume":"106","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0226-0888","authenticated-orcid":false,"given":"Christian","family":"Frerker","sequence":"first","affiliation":[{"name":"Department of Cardiology University Hospital of Schleswig\u2010Holstein L\u00fcbeck Germany"},{"name":"German Center for Cardiovascular Research (DZHK) Partner Site Hamburg\u2010Kiel\u2010L\u00fcbeck L\u00fcbeck Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arne","family":"Schwindt","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery St. Franziskus Hospital M\u00fcnster M\u00fcnster Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrej","family":"Schmidt","sequence":"additional","affiliation":[{"name":"Clinic and Polyclinic for Angiology Medical Faculty of the University Leipzig Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Schmidt","sequence":"additional","affiliation":[{"name":"Department of Cardiology University Hospital of Schleswig\u2010Holstein L\u00fcbeck Germany"},{"name":"German Center for Cardiovascular Research (DZHK) Partner Site Hamburg\u2010Kiel\u2010L\u00fcbeck L\u00fcbeck Germany"},{"name":"Department of Cardiology Asklepios Westklinikum Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillaume","family":"Bonnet","sequence":"additional","affiliation":[{"name":"RHU Envisage ANR\u201023\u2010RHUS\u20100007 M\u00fcnster France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Branzan","sequence":"additional","affiliation":[{"name":"Clinic and Polyclinic for Vascular and Endovascular Surgery TUM University Hospital, Clinic Rechts Der Isar, Technical University of Munich Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lionel","family":"Leroux","sequence":"additional","affiliation":[{"name":"RHU Envisage ANR\u201023\u2010RHUS\u20100007 M\u00fcnster France"},{"name":"Medico\u2010Surgical Department Haut\u2010L\u00e9v\u00eaque Cardiological Hospital, Bordeaux University Hospital Pessac France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2732-1205","authenticated-orcid":false,"given":"Nicolas M.","family":"Van Mieghem","sequence":"additional","affiliation":[{"name":"Department of Cardiology Thoraxcenter, Cardiovascular Institute, Erasmus Medical Center Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vasileios","family":"Panoulas","sequence":"additional","affiliation":[{"name":"Department of Cardiology Royal Brompton &amp; Harefield Hospital, Guy's and St Thomas' NHS Foundation Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Martin","sequence":"additional","affiliation":[{"name":"Vivasure Medical Ltd. Galway Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Gatto","sequence":"additional","affiliation":[{"name":"Department of Cardiology Saarland\u2010Heilst\u00e4tten GmbH, SHG\u2010Kliniken V\u00f6lklingen V\u00f6lklingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"Frontier V Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,7]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/jocs.14909"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2012.06.042"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1814052"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1816885"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.119.008227"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2012.05.005"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.109.877407"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00392-017-1097-y"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.119.007258"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2020.09.052"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2018.04.065"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.121.057856"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00392-022-02145-5"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.31574","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.31574","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.31574","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T06:09:09Z","timestamp":1771222149000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.31574"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,7]]},"references-count":13,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,7]]}},"alternative-id":["10.1002\/ccd.31574"],"URL":"https:\/\/doi.org\/10.1002\/ccd.31574","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,7]]},"assertion":[{"value":"2025-01-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-27","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-07","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}