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.

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Key information

Conditions

Renal Aneurysm Aneurysm Aneurysm Abdominal Aneurysm Thoracic Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracic Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen Aortic Center, Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

Clinical success

Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study 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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Dec 2, 2021
Registry last updated: May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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