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).
Competing Interests: Declarations. Ethics approval and consent to participate: This study was conducted in accordance with the principles outlined in the Declaration of Helsinki and adhered to ethical guidelines for medical research involving human subjects. Ethical approval for the study was obtained from the Ethic Committees in the participating sites, as listed below: Country Site Ethics Committee Competent Authority Other Belgium AZ Sint-Blasius Dendermonde CIP v1.0 approved on 13DEC2021 by Comité voor Medische Ethiek UZA (central EC) No submission required Not applicable France Hôpital Paris Saint Joseph CIP v1.0 approved on 2DEC2021 by CPP OUEST I (central EC) Accepted by ANSM on 26NOV2021 CNIL declaration n°2,223,359 performed 24AUG2021 Germany Universitäts-Herzzentrum Freiburg Bad Krozingen CIP approved on 17MAR2022 by Ethics Committee of the Albert Ludwig University of Freiburg (local EC) No submission required Not applicable All participants provided informed consent prior to their inclusion in the study. They were thoroughly informed about the study’s 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’ data were strictly maintained. Consent for publication: Not applicable. Competing interests: 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.
(© 2025. The Author(s).)