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

Completed

• Conditions: Renal Aneurysm; Aneurysm Thoracic; Aneurysm Abdominal
• Interventions: Procedure: Complex Endovascular Aortic Procedures treated by Preloaded Fenestrated Stent-graft Designs for

• Registration Number: NCT05141123
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-02
• Study Start: 2022-10-30
• Status Verified: 2023-04
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 741

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preloaded Fenestrated Stent-graft Designs for Endovascular Aortic Procedures	Complex Endovascular Aortic Procedures treated by Preloaded Fenestrated Stent-graft Designs for	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)

Primary Outcome Measures

Name	Time	Method
Clinical success	30 days	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

Trial Locations

Locations (19)

Timone Hospital Marseille; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Nantes; 🇫🇷 Nantes, France

UMass Memorial Center for Complex Aortic Disease; 🇺🇸 Worcester, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay; 🇫🇷 Paris, France

Southwestern Medical Center, Dallas; 🇺🇸 Dallas, Texas, United States

McGovern Medical School; 🇺🇸 Houston, Texas, United States

Vascular Center Malmö, Skåne University Hospital; 🇸🇪 Malmö, Sweden

Department of Surgical Sciences, Vascular Surgery, Uppsala University; 🇸🇪 Uppsala, Sweden

University of Washington Seatle; 🇺🇸 Seattle, Washington, United States

Policlinico S. Orsola Malpighi; 🇮🇹 Bologna, Italy

Centre Hospitalier Universitaire; 🇫🇷 Lille, France

Copenhagen Aortic Center; 🇩🇰 Copenhagen, Denmark

Hamburg Aortic Center; 🇩🇪 Hamburg, Germany

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Kings College; 🇬🇧 London, United Kingdom

Ludwig Maximilian University Hospital; 🇩🇪 Munich, Germany

St. Franziskus Hospital; 🇩🇪 Münster, Germany

Hospital Doctor Peset; 🇪🇸 Valencia, Spain