Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures

Aneurysm Abdominal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141123
• Other study ID #: Preloaded Registry
• Status: Completed
• Start date: October 30, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: April 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Abdominal
• Aneurysm Thoracic
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic

Intervention

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

Locations

Country	Name	City	State
Denmark	Copenhagen Aortic Center	Copenhagen
France	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
Germany	Hamburg Aortic Center	Hamburg
Germany	Ludwig Maximilian University Hospital	Munich
Germany	St. Franziskus Hospital	Münster
Italy	Policlinico S. Orsola Malpighi	Bologna
Spain	Hospital Doctor Peset	Valencia
Sweden	Vascular Center Malmö, Skåne University Hospital	Malmö
Sweden	Department of Surgical Sciences, Vascular Surgery, Uppsala University	Uppsala
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Kings College	London
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Southwestern Medical Center, Dallas	Dallas	Texas
United States	McGovern Medical School	Houston	Texas
United States	University of Washington Seatle	Seattle	Washington
United States	UMass Memorial Center for Complex Aortic Disease	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Countries where clinical trial is conducted

United States,  Denmark,  France,  Germany,  Italy,  Spain,  Sweden,  United Kingdom, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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