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The aim of the study is to evaluate the outcomes of the preloaded stent-graft design (PLD) in the routine treatment of para-renal and thoraco-abdominal aneurysms. Results and postoperative events are reported in accordance with 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.
The Registry will include approximately 300 patients treated from January 2015 to May 2021 (retrospective arm) and June 2021 to June 2023 (perspective arm) for the routine treatment of para-renal and thoraco-abdominal aneurysms. To reach 300 patients, the enrollments can be extended until June 2026.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preloaded Fenestrated Stent-graft Designs for Endovascular Aortic Procedures | Patients presenting with an acute (up to two weeks from the onset) and subacute (between 3 and 12 weeks from the onset) type B dissection with a proximal suitable non-dissected landing zone in the aortic arch or descending thoracic aorta (supra-aortic trunks debranching may be employed to obtain an adequate proximal landing zone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complex Endovascular Aortic Procedures treated by Preloaded Fenestrated Stent-graft Designs for | Procedure | Evaluate the outcomes of the preloaded stent-graft design (PLD) in the routine treatment of para-renal and thoraco-abdominal aneurysms |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success | absence of death, type I/III endoleak, graft infection/thrombosis, aneurysm expansion and/or rupture, conversion to open repair, or new treatment-related thoraco-abdominal pathologies | 30 days |
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Inclusion Criteria:
-Patients presenting with an acute (up to two weeks from the onset) and subacute (between 3 and 12 weeks from the onset) type B dissection with a proximal suitable non-dissected landing zone in the aortic arch or descending thoracic aorta (supra-aortic trunks debranching may be employed to obtain an adequate proximal landing zone
Exclusion Criteria:
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The study will include approximately 300 patients treated from January 2015 to May 2021 (retrospective arm) and June 2021 to June 2023 (perspective arm) for the routine treatment of para-renal and thoraco-abdominal aneurysms. To reach 300 patients, the enrollments can be extended until June 2026.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| UMass Memorial Center for Complex Aortic Disease |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16678676 | Background | Greenberg RK, West K, Pfaff K, Foster J, Skender D, Haulon S, Sereika J, Geiger L, Lyden SP, Clair D, Svensson L, Lytle B. Beyond the aortic bifurcation: branched endovascular grafts for thoracoabdominal and aortoiliac aneurysms. J Vasc Surg. 2006 May;43(5):879-86; discussion 886-7. doi: 10.1016/j.jvs.2005.11.063. | |
| 19233600 | Background |
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| Worcester |
| Massachusetts |
| 01605 |
| United States |
| Southwestern Medical Center, Dallas | Dallas | Texas | 75390 | United States |
| McGovern Medical School | Houston | Texas | 77030 | United States |
| University of Washington Seatle | Seattle | Washington | 98101 | United States |
| Copenhagen Aortic Center | Copenhagen | Denmark |
| Centre Hospitalier Universitaire | Lille | France |
| Timone Hospital Marseille | Marseille | France |
| Centre Hospitalier Universitaire de Nantes | Nantes | France |
| Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay | Paris | France |
| Hamburg Aortic Center | Hamburg | Germany |
| Ludwig Maximilian University Hospital | Munich | Germany |
| St. Franziskus Hospital | Münster | Germany |
| Policlinico S. Orsola Malpighi | Bologna | Italy |
| Hospital Doctor Peset | Valencia | Spain |
| Vascular Center Malmö, Skåne University Hospital | Malmö | Sweden |
| Department of Surgical Sciences, Vascular Surgery, Uppsala University | Uppsala | Sweden |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom |
| Kings College | London | United Kingdom |
| Mohabbat W, Greenberg RK, Mastracci TM, Cury M, Morales JP, Hernandez AV. Revised duplex criteria and outcomes for renal stents and stent grafts following endovascular repair of juxtarenal and thoracoabdominal aneurysms. J Vasc Surg. 2009 Apr;49(4):827-37; discussion 837. doi: 10.1016/j.jvs.2008.11.024. Epub 2009 Feb 23. |
| 20681756 | Background | Manning BJ, Harris PL, Hartley DE, Ivancev K. Preloaded fenestrated stent-grafts for the treatment of juxtarenal aortic aneurysms. J Endovasc Ther. 2010 Aug;17(4):449-55. doi: 10.1583/10-3024.1. |
| 23611709 | Background | Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):291-300. doi: 10.1016/j.jvs.2012.12.087. Epub 2013 Apr 20. |
| 23914852 | Background | Bisdas T, Donas KP, Torsello G, Austermann M. Technical assessment of the preloaded fenestrated stent-graft in the management of pararenal aortic aneurysms. J Endovasc Ther. 2013 Aug;20(4):461-8. doi: 10.1583/13-4310.1. |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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