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

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

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.

Study Overview

• Status: Completed
• Conditions: Aneurysm Thoracic; Aneurysm Abdominal; Renal Aneurysm
• Intervention / Treatment: Procedure: Complex Endovascular Aortic Procedures treated by Preloaded Fenestrated Stent-graft Designs for

• Study Type: Observational
• Enrollment (Actual): 741

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Copenhagen Aortic Center
• France
  • Lille, France
    • Centre Hospitalier Universitaire
  • Marseille, France
    • Timone Hospital Marseille
  • Nantes, France
    • Centre Hospitalier Universitaire de Nantes
  • Paris, France
    • Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay
• Germany
  • Hamburg, Germany
    • Hamburg Aortic Center
  • Munich, Germany
    • Ludwig Maximilian University Hospital
  • Münster, Germany
    • St. Franziskus Hospital
• Italy
  • Bologna, Italy
    • Policlinico S. Orsola Malpighi
• Spain
  • Valencia, Spain
    • Hospital Doctor Peset
• Sweden
  • Malmö, Sweden
    • Vascular Center Malmö, Skåne University Hospital
  • Uppsala, Sweden
    • Department of Surgical Sciences, Vascular Surgery, Uppsala University
• United Kingdom
  • Birmingham, United Kingdom
    • University Hospitals Birmingham NHS Foundation Trust
  • London, United Kingdom
    • Kings College
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Center for Complex Aortic Disease
  • Texas
    • Dallas, Texas, United States, 75390
      • Southwestern Medical Center, Dallas
    • Houston, Texas, United States, 77030
      • McGovern Medical School
  • Washington
    • Seattle, Washington, United States, 98101
      • University of Washington Seatle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aortic Aneurysm; Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: Preloaded Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No