Clinical trial NCT05956873: Endovascular Aortic Repair of Free and Contained Ruptured Thoraco-Abdominal Aortic Aneurysm
Official title: Multi-center Study on the Endovascular Aortic Repair of Free and Contained Ruptured Thoraco-Abdominal Aortic Aneurysm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracoabdominal Aortic Aneurysm
Ruptured Thoracic Aneurysm
Ruptured Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm, Ruptured
Keywords: Ruptured Thoracoabdominal aortic aneurysm
fenestrated endovascular repair
branched endovascular repair
contained rupture aneurysms
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included were all treated for rupture TAAAs in urgent setting using an off-the-shelf stent grafts, or a custom made available fenestrated and branched device, or a physician-modified endografts with fenestrations/branches or in-situ laser fenestration or parallel endografting for renal and visceral arteries.

o An urgent procedure that is carried out immediately after patient admission or within the first 24-hours.

Brief 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.

Eligibility criteria: Inclusion Criteria:

Age: Adults Gender: Male and Female Diagnosis of TAAA (Crawford I-V), penetrating aortic ulcers, or failure of previous EVAR, which require proximal landing zone above the celiac trunk. Different etiologies will be accepted with similar anatomical extend (degenerative, post-dissection, inflammatory, etc.) Free and contained ruptured TAAA confirmed by pre-operative computed tomography angiography (CTA).

Patient presenting with and without hemodynamic instability. A free-rupture is considered an aortic rupture with evidence of bleeding outside the aortic wall.

A contained rupture is considered if the integrity of the aortic wall is lots, without clear evidence of bleeding, but with periaortic structures imbibition and periaortic hematoma.

Hemodynamic instability is defined as the presence of cardiopulmonary arrest or the inability to achieve or to maintain a systolic blood pressure \> 90 mmHg despite appropriate fluid resuscitation.

Exclusion Criteria:

Patients treated with open or hybrid repair. Patients with TAAA without any sign of aortic wall rupture or without pre-operative CTA.

Patient with contained rupture presenting with no symptoms and discovered accidentally Patient that were transferred to normal wards in the period from diagnosis to procedure or can be treated in elective setting.

Primary outcomes:
measure: Rate of Technical Success
timeFrame: Within first post-operative day
measure: Rate of early mortality
timeFrame: Within 30-days from the procedure.
measure: Rate of overall survival
timeFrame: Within 60-months from the procedure
Secondary outcomes:
measure: Rate of Major Adverse events (MAEs) and rate early re interventions
timeFrame: Within 30-days from the procedure.
measure: rate of freedom from reintervention
timeFrame: Within 60-months from the procedure
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
state: Emilia Romagna
Study officials:
References:
citation: Locham SS, Grimm JC, Arhuidese IJ, Nejim B, Obeid T, Black JH 3rd, Malas MB. Perioperative Outcomes of Open versus Endovascular Repair for Ruptured Thoracoabdominal Aneurysms. Ann Vasc Surg. 2017 Oct;44:128-135. doi: 10.1016/j.avsg.2017.02.015. Epub 2017 May 10.
citation: Oderich GS, Forbes TL, Chaer R, Davies MG, Lindsay TF, Mastracci T, Singh MJ, Timaran C, Woo EY; Writing Committee Group. Reporting standards for endovascular aortic repair of aneurysms involving the renal-mesenteric arteries. J Vasc Surg. 2021 Jan;73(1S):4S-52S. doi: 10.1016/j.jvs.2020.06.011. Epub 2020 Jun 29.
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citation: Tsilimparis N, Gouveia E Melo R, Schanzer A, Sobocinski J, Austermann M, Chiesa R, Resch T, Gargiulo M, Timaran C, Maurel B, Adam D, Dias N, Oderich GS, Kolbel T, Gomez Palones F, Simonte G, Giudice R, Mesnard T, Loschi D, Leone N, Gallito E, Spath P, Porras Colon J, Elboushi A, Wachtmeister M, Sonesson B, Tenorio E, Panuccio G, Isernia G, Bertoglio L. Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair. J Vasc Surg. 2023 Oct;78(4):863-873.e3. doi: 10.1016/j.jvs.2023.05.043. Epub 2023 Jun 16.
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