Abstract
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).