Yann Gouëffic, Koen Deloose, Maxime Dubosq, Thomas Zeller
{"title":"FEMOSEAL CLOSE：外周经皮血管内手术后使用FEMOSEAL™血管关闭装置的多中心观察研究。","authors":"Yann Gouëffic, Koen Deloose, Maxime Dubosq, Thomas Zeller","doi":"10.1186/s42155-025-00522-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The purpose of the FEMOSEAL CLOSE study was to assess the safety and effectiveness of FemoSeal™ vascular closure device in achieving haemostasis following transfemoral peripheral procedures in routine clinical practice.</p><p><strong>Materials and methods: </strong>This prospective, European, multi-centre, single-arm, post-market clinical follow-up study enrolled patients undergoing diagnostic or interventional peripheral endovascular procedures with FemoSeal™ 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 h. Secondary endpoints included: minor access-site complications and major complications 6 h 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.</p><p><strong>Results: </strong>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: 91.46-97.55] of patients. The effectiveness component was achieved in 96.9% (219/226) [95% confidence interval: 93.70-98.70], and the safety component in 95.2% (220/230) [95% confidence interval: 92.15-97.90] of patients. FemoSeal™ 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 min.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>The study is registered at clinicaltrials.gov. (ClinicalTrials identifier: NCT05027698).</p>","PeriodicalId":52351,"journal":{"name":"CVIR Endovascular","volume":"8 1","pages":"15"},"PeriodicalIF":1.2000,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11846783/pdf/","citationCount":"0","resultStr":"{\"title\":\"FEMOSEAL CLOSE: multi-centre observational study with FemoSeal™ vascular closure device following peripheral percutaneous endovascular procedures.\",\"authors\":\"Yann Gouëffic, Koen Deloose, Maxime Dubosq, Thomas Zeller\",\"doi\":\"10.1186/s42155-025-00522-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The purpose of the FEMOSEAL CLOSE study was to assess the safety and effectiveness of FemoSeal™ vascular closure device in achieving haemostasis following transfemoral peripheral procedures in routine clinical practice.</p><p><strong>Materials and methods: </strong>This prospective, European, multi-centre, single-arm, post-market clinical follow-up study enrolled patients undergoing diagnostic or interventional peripheral endovascular procedures with FemoSeal™ 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 h. Secondary endpoints included: minor access-site complications and major complications 6 h 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.</p><p><strong>Results: </strong>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: 91.46-97.55] of patients. The effectiveness component was achieved in 96.9% (219/226) [95% confidence interval: 93.70-98.70], and the safety component in 95.2% (220/230) [95% confidence interval: 92.15-97.90] of patients. FemoSeal™ 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 min.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>The study is registered at clinicaltrials.gov. (ClinicalTrials identifier: NCT05027698).</p>\",\"PeriodicalId\":52351,\"journal\":{\"name\":\"CVIR Endovascular\",\"volume\":\"8 1\",\"pages\":\"15\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2025-02-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11846783/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"CVIR Endovascular\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s42155-025-00522-5\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"CVIR Endovascular","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s42155-025-00522-5","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
FEMOSEAL CLOSE: multi-centre observational study with FemoSeal™ vascular closure device following peripheral percutaneous endovascular procedures.
Background: The purpose of the FEMOSEAL CLOSE study was to assess the safety and effectiveness of FemoSeal™ vascular closure device in achieving haemostasis following transfemoral peripheral procedures in routine clinical practice.
Materials and methods: This prospective, European, multi-centre, single-arm, post-market clinical follow-up study enrolled patients undergoing diagnostic or interventional peripheral endovascular procedures with FemoSeal™ 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 h. Secondary endpoints included: minor access-site complications and major complications 6 h 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.
Results: 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: 91.46-97.55] of patients. The effectiveness component was achieved in 96.9% (219/226) [95% confidence interval: 93.70-98.70], and the safety component in 95.2% (220/230) [95% confidence interval: 92.15-97.90] of patients. FemoSeal™ 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 min.
Conclusions: 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.
Trial registration: The study is registered at clinicaltrials.gov. (ClinicalTrials identifier: NCT05027698).
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