FEMOSEAL CLOSE: multi-centre observational study with FemoSeal™ vascular closure device following peripheral percutaneous endovascular procedures.

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 acces

SUBMITTER: Goueffic Y 

PROVIDER: S-EPMC11846783 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature