Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
The Frontier V Study: Evaluating the Safety and Clinical Performance of a Large-Bore Vascular Closure Device After Femoral Arterial Access.
Clinical StudyСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
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Frerker Christian, Schwindt Arne, Schmidt Andrej, Schmidt Tobias, Bonnet Guillaume, Branzan Daniela, Leroux Lionel, Van Mieghem Nicolas M, Panoulas Vasileios, Martin Christopher, Gatto Fernando, Frontier V Investigators
Аннотация
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.
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.