ArticleCVIR endovascular2025
FEMOSEAL CLOSE: multi-centre observational study with FemoSeal™ vascular closure device following peripheral percutaneous endovascular procedures.
Article in CVIR endovascular, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05027698 (FEMOSEAL CLOSE - Post-Market Clinical Investigation of the FemoSeal™ VCS), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
FEMOSEAL CLOSE - Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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
methodsThis 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.
resultsBetween 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.
conclusionsThe 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 registrationThe study is registered at clinicaltrials.gov. (ClinicalTrials identifier: NCT05027698).
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