Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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) |
Procedure: Complex Endovascular Aortic Procedures treated by Preloaded Fenestrated Stent-graft Designs for
Evaluate the outcomes of the preloaded stent-graft design (PLD) in the routine treatment of para-renal and thoraco-abdominal aneurysms
|
Outcome Measures
Primary Outcome Measures
- Clinical success [30 days]
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
Eligibility Criteria
Criteria
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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Anatomy requiring sealing in the distal descending thoracic aorta may not be appropriate for a 50 cm sheath due to the risk of it being too short and the graft not reaching the intended landing zone;
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Celiac trunk or superior mesenteric branch design that makes the graft excessively long;
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Inability or refusal to give informed consent;
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Simultaneously participating in another investigative device or drug study;
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Frank rupture;
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Systemic infection (eg, sepsis);
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Allergy to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold;
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Untreatable reaction to contrast, which, in the opinion of the investigator, cannot be adequately premedicated.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 2 | UMass Memorial Center for Complex Aortic Disease | Worcester | Massachusetts | United States | 01605 |
| 3 | Southwestern Medical Center, Dallas | Dallas | Texas | United States | 75390 |
| 4 | McGovern Medical School | Houston | Texas | United States | 77030 |
| 5 | University of Washington Seatle | Seattle | Washington | United States | 98101 |
| 6 | Copenhagen Aortic Center | Copenhagen | Denmark | ||
| 7 | Centre Hospitalier Universitaire | Lille | France | ||
| 8 | Timone Hospital Marseille | Marseille | France | ||
| 9 | Centre Hospitalier Universitaire de Nantes | Nantes | France | ||
| 10 | Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay | Paris | France | ||
| 11 | Hamburg Aortic Center | Hamburg | Germany | ||
| 12 | Ludwig Maximilian University Hospital | Munich | Germany | ||
| 13 | St. Franziskus Hospital | Münster | Germany | ||
| 14 | Policlinico S. Orsola Malpighi | Bologna | Italy | ||
| 15 | Hospital Doctor Peset | Valencia | Spain | ||
| 16 | Vascular Center Malmö, Skåne University Hospital | Malmö | Sweden | ||
| 17 | Department of Surgical Sciences, Vascular Surgery, Uppsala University | Uppsala | Sweden | ||
| 18 | University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom | ||
| 19 | Kings College | London | United Kingdom |
Sponsors and Collaborators
- IRCCS San Raffaele
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Preloaded Registry