NCT05141123

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 741 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-30
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2021-12-02
• Last updated: 2023-05-01

Locations

19 sites across 8 countries: United States, Denmark, France, Germany, Italy, Spain, Sweden, United Kingdom