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

NCT05141123 | Completed

• 1 other identifier: Preloaded Registry
• Study Type: observational
• Target: 741
• Locations: 8 countries
• Sites: 19

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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

Preloaded Fenestrated Stent-graft Designs for Endovascular Aortic Procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (19)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

UMass Memorial Center for Complex Aortic Disease

Worcester, Massachusetts, 01605, United States

Location

Southwestern Medical Center, Dallas

Dallas, Texas, 75390, United States

Location

McGovern Medical School

Houston, Texas, 77030, United States

Location

University of Washington Seatle

Seattle, Washington, 98101, United States

Location

Copenhagen Aortic Center

Copenhagen, Denmark

Location

Centre Hospitalier Universitaire

Lille, France

Location

Timone Hospital Marseille

Marseille, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, France

Location

Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay

Paris, France

Location

Hamburg Aortic Center

Hamburg, Germany

Location

Ludwig Maximilian University Hospital

Munich, Germany

Location

St. Franziskus Hospital

Münster, Germany

Location

Policlinico S. Orsola Malpighi

Bologna, Italy

Location

Hospital Doctor Peset

Valencia, Spain

Location

Vascular Center Malmö, Skåne University Hospital

Malmo, Sweden

Location

Department of Surgical Sciences, Vascular Surgery, Uppsala University

Uppsala, Sweden

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Kings College

London, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 16678676 BACKGROUND

• 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.

  PMID: 19233600 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.

  PMID: 20681756 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.

  PMID: 23611709 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.

  PMID: 23914852 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: October 30, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); IT (1); SE (2); US (5); DK (1); FR (4); ES (1); GB (2)