Clinical trial NCT05141123: Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures
Official title: A Physician-initiated, International, Multi-center, Retrospective and Prospective, Observational Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Aneurysm
Aneurysm Thoracic
Aneurysm Abdominal
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 741
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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:

* 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;
* Celiac trunk or superior mesenteric branch design that makes the graft excessively long;
* Inability or refusal to give informed consent;
* Simultaneously participating in another investigative device or drug study;
* Frank rupture;
* Systemic infection (eg, sepsis);
* Allergy to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold;
* Untreatable reaction to contrast, which, in the opinion of the investigator, cannot be adequately premedicated.

Primary outcomes:
measure: Clinical success
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Center for Complex Aortic Disease
state: Massachusetts
city: Dallas
country: United States
facility: Southwestern Medical Center, Dallas
state: Texas
city: Houston
country: United States
facility: McGovern Medical School
state: Texas
city: Seattle
country: United States
facility: University of Washington Seatle
state: Washington
city: Copenhagen
country: Denmark
facility: Copenhagen Aortic Center
city: Lille
country: France
facility: Centre Hospitalier Universitaire
city: Marseille
country: France
facility: Timone Hospital Marseille
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay
city: Hamburg
country: Germany
facility: Hamburg Aortic Center
city: Munich
country: Germany
facility: Ludwig Maximilian University Hospital
city: Münster
country: Germany
facility: St. Franziskus Hospital
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Malmö
country: Sweden
facility: Vascular Center Malmö, Skåne University Hospital
city: Uppsala
country: Sweden
facility: Department of Surgical Sciences, Vascular Surgery, Uppsala University
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings College
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.