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Войти в исследования JMIR research protocols · 2026
GORE VIABAHN VBX Balloon-Expandable Endoprostheses as a Bridging Stent With Branched and Fenestrated Endografts in the Endovascular Treatment of Aortic Aneurysms: Protocol for a Retrospective Multicenter Registry (EMBRACE Study).
СтатьяНазвание и аннотация: Перевод в очереди
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Dioni Pietro, Wanhainen Anders, Budtz-Lilly Jacob, Dias Nuno, Bonny Tab, Bertoglio Luca, EMBRACE study investigator
Аннотация
BACKGROUND: Covered stents commercially available are frequently used off-label in conjunction with fenestrated and branched aortic stent grafts, but there is a lack of dedicated devices.
OBJECTIVE: This study aims to assess the safety and mid-term clinical performance of a new dedicated covered stent, the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX stent graft), when used as a bridging stent with branched and fenestrated aortic endografts in treating complex abdominal aortic and thoraco-abdominal aneurysms.
METHODS: A retrospective, multicenter, single-arm study in the European Union (ClinicalTrials.gov NCT05143138) enrolled patients treated with the VBX stent graft as a bridging stent in branched endovascular repair (BEVAR) and fenestrated endovascular repair (FEVAR) to allow endovascular aneurysm repair between January 2017 and December 2021. Up to 15 sites in Europe were required to enroll a minimum of 220 patients. Patients' medical records were reviewed by the investigator, and specific data were collected ambispectively for up to 5 years of follow-up from the index procedure. The primary end point is target vessel patency (patient level) through 12 months. The registry was designed to statistically test target vessel patency at 12 months in both FEVAR and BEVAR populations. The hypothesis will be tested separately in the 2 cohorts (fenestrated or branched endovascular repair), using patients with core laboratory imaging results available annually through 5 years. The binomial exact test will be used with a 1-sided 2.5% level of significance to test the null hypothesis.
RESULTS: In total, 259 patients were retrospectively enrolled for a prospective follow-up of 5 years: 136 patients (n=99, 72.8% male; mean age 73, SD 8.9 y) in the BEVAR cohort, 92 patients (n=80, 87.0% male, mean age 72.7, SD 8.1 y) in the FEVAR cohort, and 31 patients (n=17, 54.8% male, mean age 70.9, SD 9.4 y) in the mixed fenestrated or branched endovascular repair cohort. Overall, 662 target vessels were stented with the investigational covered stents: 163 (24.6%) celiac trunk, 192 (29.0%) superior mesenteric artery, and 307 (46.4%) renal arteries. The VBX stent grafts were paired with branches in 451 (68.1%) cases or fenestrations in 211 (31.9%) cases among all Cook Medical stent graft cases. The 1-year results will be published in the fourth quarter of 2025, and the 5-year follow-up results will be analyzed by mid-year 2028.
CONCLUSIONS: This study will investigate the VBX stent graft performance in combination with fenestrated and branched aortic grafts to corroborate its use in complex aortic endovascular procedures and support the modification of current device instructions for use.
OBJECTIVE: This study aims to assess the safety and mid-term clinical performance of a new dedicated covered stent, the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX stent graft), when used as a bridging stent with branched and fenestrated aortic endografts in treating complex abdominal aortic and thoraco-abdominal aneurysms.
METHODS: A retrospective, multicenter, single-arm study in the European Union (ClinicalTrials.gov NCT05143138) enrolled patients treated with the VBX stent graft as a bridging stent in branched endovascular repair (BEVAR) and fenestrated endovascular repair (FEVAR) to allow endovascular aneurysm repair between January 2017 and December 2021. Up to 15 sites in Europe were required to enroll a minimum of 220 patients. Patients' medical records were reviewed by the investigator, and specific data were collected ambispectively for up to 5 years of follow-up from the index procedure. The primary end point is target vessel patency (patient level) through 12 months. The registry was designed to statistically test target vessel patency at 12 months in both FEVAR and BEVAR populations. The hypothesis will be tested separately in the 2 cohorts (fenestrated or branched endovascular repair), using patients with core laboratory imaging results available annually through 5 years. The binomial exact test will be used with a 1-sided 2.5% level of significance to test the null hypothesis.
RESULTS: In total, 259 patients were retrospectively enrolled for a prospective follow-up of 5 years: 136 patients (n=99, 72.8% male; mean age 73, SD 8.9 y) in the BEVAR cohort, 92 patients (n=80, 87.0% male, mean age 72.7, SD 8.1 y) in the FEVAR cohort, and 31 patients (n=17, 54.8% male, mean age 70.9, SD 9.4 y) in the mixed fenestrated or branched endovascular repair cohort. Overall, 662 target vessels were stented with the investigational covered stents: 163 (24.6%) celiac trunk, 192 (29.0%) superior mesenteric artery, and 307 (46.4%) renal arteries. The VBX stent grafts were paired with branches in 451 (68.1%) cases or fenestrations in 211 (31.9%) cases among all Cook Medical stent graft cases. The 1-year results will be published in the fourth quarter of 2025, and the 5-year follow-up results will be analyzed by mid-year 2028.
CONCLUSIONS: This study will investigate the VBX stent graft performance in combination with fenestrated and branched aortic grafts to corroborate its use in complex aortic endovascular procedures and support the modification of current device instructions for use.