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

NCT ID: NCT05141123

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 741 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-30
• Study Completion Date: 2023-04-20

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.

Conditions

Renal Aneurysm; Aneurysm Thoracic; Aneurysm Abdominal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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)

Complex Endovascular Aortic Procedures treated by Preloaded Fenestrated Stent-graft Designs for

Intervention Type: PROCEDURE

Evaluate the outcomes of the preloaded stent-graft design (PLD) in the routine treatment of para-renal and thoraco-abdominal aneurysms

Interventions

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Bertoglio Luca

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

UMass Memorial Center for Complex Aortic Disease

Worcester, 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

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

Malmo, , 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

Countries

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

References

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.

Reference Type: BACKGROUND

PMID: 16678676 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19233600 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20681756 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23611709 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23914852 (View on PubMed)

Other Identifiers

Preloaded Registry

Identifier Type: -

Identifier Source: org_study_id