{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,23]],"date-time":"2025-02-23T05:12:23Z","timestamp":1740287543761,"version":"3.37.3"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,2,22]],"date-time":"2025-02-22T00:00:00Z","timestamp":1740182400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,2,22]],"date-time":"2025-02-22T00:00:00Z","timestamp":1740182400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["CVIR Endovasc"],"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>The purpose of the FEMOSEAL CLOSE study was to assess the safety and effectiveness of FemoSeal\u2122 vascular closure device in achieving haemostasis following transfemoral peripheral procedures in routine clinical practice.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Materials and methods<\/jats:title>\n            <jats:p>This prospective, European, multi-centre, single-arm, post-market clinical follow-up study enrolled patients undergoing diagnostic or interventional peripheral endovascular procedures with FemoSeal\u2122 vascular closure device in inpatient or outpatient settings. The primary endpoint was a composite of safety and effectiveness, with effectiveness defined as cessation of arterial bleeding without adjunctive treatment, and safety as freedom from major vascular complications in the first 6\u00a0h. Secondary endpoints included: minor access-site complications and major complications 6\u00a0h to 30 days post-procedure, and time to haemostasis, ambulation and discharge. Quality of life was assessed at baseline, discharge and 30-day follow-up. Device usability was also surveyed.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Between December 2021 and July 2022, 230 patients were enrolled in three European centres. The primary composite endpoint was achieved in 95.1% (215\/226) [95% confidence interval: 91.46\u201397.55] of patients. The effectiveness component was achieved in 96.9% (219\/226) [95% confidence interval: 93.70\u201398.70], and the safety component in 95.2% (220\/230) [95% confidence interval: 92.15\u201397.90] of patients. FemoSeal\u2122 vascular closure device deployment failure occurred in 1.6% (4\/230) of cases, with subsequent manual compression achieving haemostasis. The median time to haemostasis was 0.42\u00a0min.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>The study device provides effective haemostasis and low rates of access-site complications up to 30 days post-procedure for patients undergoing peripheral endovascular interventions. It demonstrates good performance with rapid haemostasis.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial registration<\/jats:title>\n            <jats:p>The study is registered at clinicaltrials.gov. (ClinicalTrials identifier: NCT05027698).<\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/s42155-025-00522-5","type":"journal-article","created":{"date-parts":[[2025,2,22]],"date-time":"2025-02-22T08:40:51Z","timestamp":1740213651000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["FEMOSEAL CLOSE: multi-centre observational study with FemoSeal\u2122 vascular closure device following peripheral percutaneous endovascular procedures"],"prefix":"10.1186","volume":"8","author":[{"given":"Yann","family":"Gou\u00ebffic","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koen","family":"Deloose","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maxime","family":"Dubosq","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Zeller","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,2,22]]},"reference":[{"key":"522_CR1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijnurstu.2022.104364","volume":"137","author":"R Reich","year":"2023","unstructured":"Reich R, Helal L, Mantovani VM, Rabelo-Silva ER. Hemostasis control after femoral percutaneous approach: a systematic review and meta-analysis. Int J Nurs Stud. 2023;137: 104364.","journal-title":"Int J Nurs Stud"},{"key":"522_CR2","doi-asserted-by":"publisher","first-page":"8569188","DOI":"10.1155\/2022\/8569188","volume":"2022","author":"N Pang","year":"2022","unstructured":"Pang N, Gao J, Zhang B, et al. Vascular closure devices versus manual compression in cardiac interventional procedures: systematic review and meta-analysis. Cardiovasc Ther. 2022;2022:8569188.","journal-title":"Cardiovasc Ther"},{"key":"522_CR3","doi-asserted-by":"publisher","first-page":"183","DOI":"10.4244\/EIJV10I2A31","volume":"10","author":"NR Holm","year":"2014","unstructured":"Holm NR, Sindberg B, Schou M, et al. Randomised comparison of manual compression and FemoSeal\u2122 vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices used in everyday practice (CLOSE-UP) study. 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Ethical approval for the study was obtained from the Ethic Committees in the participating sites, as listed below:\nAll participants provided informed consent prior to their inclusion in the study. They were thoroughly informed about the study\u2019s purpose, procedures, potential risks, and benefits. Participants were also assured of their right to withdraw from the study at any time without any repercussions. Consent was documented in written form, and copies of the consent documents are securely stored in accordance with institutional policies.In cases where participants were unable to provide consent personally, legal guardians or authorized representatives provided consent on their behalf. Additionally, confidentiality and anonymity of the participants\u2019 data were strictly maintained.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"YG: Research funding from: Abbott, Boston Scientific, General Electric, Veryan, WL Gore.Personal fees and grants from: Abbott, Bard, Biotronik, Boston Scientific, Cook, General Electric, Medtronic, Penumbra, Terumo, Veryan, WL Gore (medical advisory board, educational course, speaking).TZ: No conflict of interest.KD: Grant\/Research from: Abbott, Biotronik, iVascular, Terumo. Consultancy from: Abbott, BD, Bently, Biotronik, Boston Scientific, Cook, GE Healthcare.MD: No conflict of interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"15"}}