The Frontier V Study: Evaluating the Safety and Clinical Performance of a Large‐Bore Vascular Closure Device After Femoral Arterial Access

• Published in: Catheterization and cardiovascular interventions Vol. 106; no. 1; pp. 521 - 526
• Main Authors: Frerker, Christian, Schwindt, Arne, Schmidt, Andrej, Schmidt, Tobias, Bonnet, Guillaume, Branzan, Daniela, Leroux, Lionel, Van Mieghem, Nicolas M., Panoulas, Vasileios, Martin, Christopher, Gatto, Fernando
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.07.2025
• Subjects: Aged; Aged, 80 and over; Cardiovascular system; Catheterization, Peripheral - adverse effects; Endovascular Procedures - adverse effects; Equipment Design; Europe; EVAR; Female; femoral arterial access; Femoral Artery - diagnostic imaging; Femur; Hematoma; Hemorrhage - etiology; Hemorrhage - prevention & control; Hemostasis; Hemostatic Techniques - adverse effects; Hemostatic Techniques - instrumentation; Humans; large bore arterial access; Male; Middle Aged; Morbidity; Prospective Studies; Punctures; Risk Factors; Sheaths; TAVR; Time Factors; Treatment Outcome; vascular closure device; Vascular Closure Devices; vascular complications; Europe; femoral arterial access; EVAR; vascular complications; large bore arterial access; TAVR; vascular closure device
• ISSN: 1522-1946; 1522-726X; 1522-726X
• DOI: 10.1002/ccd.31574

ABSTRACT Background Vascular complications following large‐bore procedures may have a significant impact on patient morbidity and mortality, highlighting the critical need for an effective, safe, and reproducible closure device. We present our prospective multi‐center experience with a novel patch‐based closure device. Aim To evaluate the safety and clinical performance of the PerQseal+ closure system in achieving hemostasis after femoral arterial large‐bore access with 14–22 F sheaths. Methods The Frontier V study (NCT04799769) is a multicenter study that included patients undergoing an endovascular procedure requiring femoral access created by 14−22 F sheaths. The primary safety outcome was major access site complications related to the PerQseal+. The primary efficacy outcome was the technical success rate of device deployment. Secondary outcomes included minor access site complications related to the device, time to hemostasia, time to deployment, and time to total closure. Results A total of 88 subjects were included at seven investigational centers in Europe. One device‐related major access site complication (i.e., retroperitoneal hematoma) occurred (1.1%). The acute success rate of device deployment was 95%. There were five minor vascular access site complications directly related to the device (5.7%). The median time of device deployment was 5 min, the median time to achieve hemostasia was 1 min, and the median total closure time was 6 min. Conclusion The PerQseal+ closure device was safe and effective for large‐bore arterial femoral closure. These results highlight its potential as a reliable alternative for large‐bore closure in endovascular procedures.