NCT05956873

Endovascular Aortic Repair of Free and Contained Ruptured Thoraco-Abdominal Aortic Aneurysm

Multi-center Study on the Endovascular Aortic Repair of Free and Contained Ruptured Thoraco-Abdominal Aortic Aneurysm

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ruptured thoracoabdominal aortic aneurysm (TAAA) represents an emergency medical challenge that needs to be treated promptly. Over the past years different endovascular techniques have emerged such as fenestrated or branched endovascular aortic repair (FB-EVAR). However, FB-EVAR is a technique that uses a custom-made device which needs to be manufactured and this process take months, therefore, it could not be used in urgent settings. Off-the-shelf graft stents are pre-made graft stents, which can be used in urgent cases. A retrospective, multicenter cohort study was planned to include patients who underwent endovascular procedures between January 2015 and January 2022 (85 months) to evaluate the technical and survival outcomes of the use of off-the-shelf stent graft, physician-modified endograft and parallel graft technique in endovascular aortic repair of free and contained ruptured TAAA. Data will be collected anonymously and retrospectively, including patient demographics, risk factors, diagnosis and anatomical details, procedure details and post-operative outcomes.

Detailed description

The presentation of a thoracoabdominal aortic aneurysm (TAAA) represents a major clinical challenge leading to a high risk of mortality Traditional open surgical repair has a perioperative mortality risk of 53% and therefore a less invasive option is mandatory. Endovascular abdominal aortic repair (EVAR) has been proposed as the main alternative treatment to reduce mortality compared to open surgical repair, with an advantage of decreasing the risk for renal and pulmonary complications. Over the last two decades, fenestrated and branched EVAR (FB-EVAR) have been implemented as an emerging endovascular techniques for patients with complex abdominal aortic aneurysms to preserve visceral and renal arteries. FEVAR is a technique using a custom-made device, which requires a production and delivery time of about 90 days and therefore could not be used in urgent settings. However, in urgent cases off-the-shelf stent grafts have been used as alternative options, with a 30-day mortality of 14%. In these settings, and both early and follow-up survival outcomes are strongly affected by hemodynamic patient presentation that represents a main prognostic factor Nonetheless, in urgent cases in whom off-shelf stent grafts cannot be implanted due to complex anatomical configuration, physician-modified endografts (PMEG) have been proposed with an early survival rate ranging from 8% to 14%. Parallel grafts can be used as a third option, with a comparable overall mortality but with a 24% risk of developing type Ia endoleak, without a complete exclusion of the aneurysmal sac. Many papers consider free ruptures, contained symptomatic ruptures as well as large aneurysm (diameter \>80 with a high risk of ruptures) as an urgent TAAA, but since the hemodynamic status and the symptoms presentation may be strongly different, they should be addressed separately and large-number paper with the focus specifically or ruptured TAAA are still lacking Currently, off-the-shelf stent grafts, PMEG and parallel grafts have been used in many centers across the world for the treatment of ruptured and symptomatic contained ruptured TAAA. Therefore, performing a multicenter study analyzing the data collected may lead to a better understanding of the clinical features as well as the used techniques, outcomes and applicability. AIMS OF THE STUDY A retrospective multicenter, cross-sectional cohort study to evaluate the technical and survival outcomes of the use of off-the-shelf graft stent, physician-modified-endografts and parallel grafts in endovascular aortic repair of free ruptured and contained ruptured TAAA. Results and postoperative events will be reported following the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery.

Conditions

• Thoracoabdominal Aortic Aneurysm
• Ruptured Thoracic Aneurysm
• Ruptured Aortic Aneurysm
• Thoracoabdominal Aortic Aneurysm, Ruptured

Interventions

Type	Name	Description
DEVICE	REVAR	Endovascular repair of ruptured TAAAs with available technique and devices: endovascular treatments were performed in urgent or emergent setting, compulsory within the first 24 hours, using an off-the-shelf stent grafts, or an available custom-made fenestrated/branched device or a physician-modified endografts with fenestrations/branches or parallel endografting for renal and visceral arteries

Timeline

• Start date: 2015-01-01
• Primary completion: 2023-01-01
• Completion: 2023-07-01
• First posted: 2023-07-24
• Last updated: 2023-07-24

Locations

1 site across 1 country: Italy