Thoracoabdominal Aortic AneurysmREVAR-TAAANCT05956873
Endovascular Aortic Repair of Free and Contained Ruptured Thoraco-Abdominal Aortic Aneurysm
An observational study of Thoracoabdominal Aortic Aneurysm and Ruptured Thoracic Aneurysm, run by University of Bologna at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm, Ruptured Thoracic Aneurysm, Ruptured Aortic Aneurysm
- What is being tested?
- REVAR
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2015to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center Study on the Endovascular Aortic Repair of Free and Contained Ruptured Thoraco-Abdominal Aortic Aneurysm
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.
Read the 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
- Being tested
- REVAR
- Keywords
- Ruptured Thoracoabdominal aortic aneurysm, fenestrated endovascular repair, branched endovascular repair, contained rupture aneurysms
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal, Aortic Rupture, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVARDevice
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
| Study group | Role | What they receive |
|---|---|---|
| RTAAA patients treated with REVAR | Included population were consecutive patients presented with evidence of active bleeding (frank ruptures), or without active bleeding but with periaortic structures infiltration/hematoma (contained rupture); undergoing urgent/emergent endovascular RTAAA (Crawford's extend I-IV + suprarenal AAA) repair within the first 24 hours, requiring a proximal landing zone above the celiac trunk with off-the-shelf, F/B-EVAR, PMEG and PG. Receives: Device: REVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Technical Success
successful endovascular access and deployment of all devices at the intended aortic location, successful catheterization and stenting of all planned target vessels, absence of type I /III endoleaks at the final angiography. The presence of hemodynamic instability at the end of procedure with evidence of bleeding and intra-operative mortality without possibility of completing the procedure, were considered technical failures.
Measured: Within first post-operative day
Rate of early mortality
We considered as a cumulative endpoint composed by perioperative mortality (within the first 48hours), 30-day Mortality, if the patient died in the first 30-day period after intervention and In-hospital mortality, if the patient died in-hospital with hospitalization time longer than 30-days.
Measured: Within 30-days from the procedure.
Rate of overall survival
Overall survival regardless the aortic relationship of the reported cause of death.
Measured: Within 60-months from the procedure
Secondary outcomes (2)
Rate of Major Adverse events (MAEs) and rate early re interventions
cardiac complications (including myocardial infarction, congestive heart failure, and myocardial ischemia requiring intervention); respiratory complications (including required prolonged >24 hours mechanical ventilation or respiratory insufficiency/pneumonia requiring reintubation and/or ventilatory assistance); acute kidney injury, defined as renal function decline resulting in >30% reduction in baseline eGFR or new-onset dialysis; major stroke, defined as the presence of invalidting neurological sequelae; spinal cord ischemia (SCI) defined as the presence of paraplegia or paraparesis, being temporary if had a complete resolution and expected return to baseline, and permanent if the injury had partial or no improvement compared with baseline examination; bowel ischemia requiring surgical resection or not resolving with medical therapy;
Measured: Within 30-days from the procedure.
rate of freedom from reintervention
Overall freedom from need for re interventions related in some extend to the REVAR procedure or RTAAAs condition
Measured: Within 60-months from the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Jan 2015
- Primary completion1 Jan 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Thoracoabdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Gallitto, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956873
- Sponsor's protocol ID
- REVAR-TAAA
- Acronym
- REVAR-TAAA
- Status last verified
- Jul 2023
- First submitted
- 1 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study is a multicenter, observational, cross-sectional cohort study to evaluate the outcomes of endovascular aortic repair of symptomatic contained and free ruptured TAAAs using off-the-shelf stent grafts and physician-modified stent grafts. The study will be a multicenter retrospective cohort including international centers. As soon as we receive positive answers from the invited centers, we will proceed to update the protocol, accordingly.
Publications
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.
PubMed 28501656Oderich 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.
PubMed 32615285Spath P, Tsilimparis N, Furlan F, Hamwi T, Prendes CF, Stana J. Additional Aortic Coverage With an Off The Shelf, Multibranched Endograft Compared With Custom Made Devices For Endovascular Repair of Pararenal Abdominal Aortic Aneurysms. Eur J Vasc Endovasc Surg. 2023 May;65(5):710-718. doi: 10.1016/j.ejvs.2023.01.030. Epub 2023 Jan 24.
PubMed 36707021Gallitto E, Faggioli G, Spath P, Pini R, Mascoli C, Logiacco A, Gargiulo M. Urgent endovascular repair of thoracoabdominal aneurysms using an off-the-shelf multibranched endograft. Eur J Cardiothorac Surg. 2022 May 2;61(5):1087-1096. doi: 10.1093/ejcts/ezab553.
PubMed 34964451Gallitto E, Faggioli G, Spath P, Pini R, Mascoli C, Ancetti S, Stella A, Abualhin M, Gargiulo M. The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft. J Vasc Surg. 2020 Jul;72(1):16-24. doi: 10.1016/j.jvs.2019.08.273. Epub 2020 Feb 13.
PubMed 32063442Tsilimparis 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.
PubMed 37330705Tsilimparis N, Bosiers M, Resch T, Torsello G, Austermann M, Rohlffs F, Coates B, Yeh C, Kolbel T. Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2023 Aug;78(2):289-298. doi: 10.1016/j.jvs.2023.03.498. Epub 2023 Apr 11.
PubMed 37044318Spath P, Tsilimparis N, Gallitto E, Becker D, Vacirca A, Berekoven B, Panuccio G, Karelis A, Kahlberg A, Melissano G, Dias N, Kolbel T, Austermann M, Faggioli G, Oderich G, Gargiulo M; International Collaborators writing committee on TAAA ruptures' study group. Endovascular Repair of 100 Urgent and Emergent Free or Contained Thoracoabdominal Aortic Aneurysms Ruptures. An International Multicenter Trans-Atlantic Experience. Ann Surg. 2025 Mar 1;281(3):522-531. doi: 10.1097/SLA.0000000000006231. Epub 2024 Feb 7.
PubMed 38323417
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study on the Endovascular Aortic Repair of Free and Contained Ruptured Thoraco-Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT05956873
- Acronym / sponsor ID
- REVAR-TAAA / REVAR-TAAA
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RTAAA patients treated with REVAR | – | Device: REVARIncluded population were consecutive patients presented with evidence of active bleeding (frank ruptures), or without active bleeding but with periaortic structures infiltration/hematoma (contained rupture); undergoing urgent/emergent endovascular RTAAA (Crawford's extend I-IV + suprarenal AAA) repair within the first 24 hours, requiring a proximal landing zone above the celiac trunk with off-the-shelf, F/B-EVAR, PMEG and PG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REVAREndovascular 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 | Device | RTAAA patients treated with REVAR |
Primary outcome
Rate of Technical Success
Time frame: Within first post-operative day
successful endovascular access and deployment of all devices at the intended aortic location, successful catheterization and stenting of all planned target vessels, absence of type I /III endoleaks at the final angiography. The presence of hemodynamic instability at the end of procedure with evidence of bleeding and intra-operative mortality without possibility of completing the procedure, were considered technical failures.
Rate of early mortality
Time frame: Within 30-days from the procedure.
We considered as a cumulative endpoint composed by perioperative mortality (within the first 48hours), 30-day Mortality, if the patient died in the first 30-day period after intervention and In-hospital mortality, if the patient died in-hospital with hospitalization time longer than 30-days.
Rate of overall survival
Time frame: Within 60-months from the procedure
Overall survival regardless the aortic relationship of the reported cause of death.
2 secondary outcomes
Rate of Major Adverse events (MAEs) and rate early re interventions
Time frame: Within 30-days from the procedure.
rate of freedom from reintervention
Time frame: Within 60-months from the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 28501656Locham 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.
- Background: PubMed 32615285Oderich 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.
- Background: PubMed 36707021Spath P, Tsilimparis N, Furlan F, Hamwi T, Prendes CF, Stana J. Additional Aortic Coverage With an Off The Shelf, Multibranched Endograft Compared With Custom Made Devices For Endovascular Repair of Pararenal Abdominal Aortic Aneurysms. Eur J Vasc Endovasc Surg. 2023 May;65(5):710-718. doi: 10.1016/j.ejvs.2023.01.030. Epub 2023 Jan 24.
- Background: PubMed 34964451Gallitto E, Faggioli G, Spath P, Pini R, Mascoli C, Logiacco A, Gargiulo M. Urgent endovascular repair of thoracoabdominal aneurysms using an off-the-shelf multibranched endograft. Eur J Cardiothorac Surg. 2022 May 2;61(5):1087-1096. doi: 10.1093/ejcts/ezab553.
- Background: PubMed 32063442Gallitto E, Faggioli G, Spath P, Pini R, Mascoli C, Ancetti S, Stella A, Abualhin M, Gargiulo M. The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft. J Vasc Surg. 2020 Jul;72(1):16-24. doi: 10.1016/j.jvs.2019.08.273. Epub 2020 Feb 13.
- Background: PubMed 37330705Tsilimparis 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.
- Background: PubMed 37044318Tsilimparis N, Bosiers M, Resch T, Torsello G, Austermann M, Rohlffs F, Coates B, Yeh C, Kolbel T. Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2023 Aug;78(2):289-298. doi: 10.1016/j.jvs.2023.03.498. Epub 2023 Apr 11.
- Derived from this study: PubMed 38323417Spath P, Tsilimparis N, Gallitto E, Becker D, Vacirca A, Berekoven B, Panuccio G, Karelis A, Kahlberg A, Melissano G, Dias N, Kolbel T, Austermann M, Faggioli G, Oderich G, Gargiulo M; International Collaborators writing committee on TAAA ruptures' study group. Endovascular Repair of 100 Urgent and Emergent Free or Contained Thoracoabdominal Aortic Aneurysms Ruptures. An International Multicenter Trans-Atlantic Experience. Ann Surg. 2025 Mar 1;281(3):522-531. doi: 10.1097/SLA.0000000000006231. Epub 2024 Feb 7.
- Individual participant dataSharing planned: Undecided. This study is a multicenter, observational, cross-sectional cohort study to evaluate the outcomes of endovascular aortic repair of symptomatic contained and free ruptured TAAAs using off-the-shelf stent grafts and physician-modified stent grafts. The study will be a multicenter retrospective cohort including international centers. As soon as we receive positive answers from the invited centers, we will proceed to update the protocol, accordingly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracoabdominal Aortic Aneurysm and Ruptured Thoracic Aneurysm, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Technical Success (time frame: Within first post-operative day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05956873, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.