Brief Title
Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures
Official 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
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.
Study Type
Observational
Primary Outcome
Clinical success
Condition
Renal Aneurysm
Intervention
Complex Endovascular Aortic Procedures treated by Preloaded Fenestrated Stent-graft Designs for
Study Arms / Comparison Groups
Preloaded Fenestrated Stent-graft Designs for Endovascular Aortic Procedures
Description: 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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
300
Start Date
October 30, 2022
Completion Date
December 31, 2023
Primary Completion Date
March 31, 2023
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +390226437381, [email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT05141123
Organization ID
Preloaded Registry
Responsible Party
Principal Investigator
Study Sponsor
IRCCS San Raffaele
Study Sponsor
, ,
Verification Date
June 2022