Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures
Completed
Conditions studied: Renal Aneurysm, Aneurysm Thoracic, Aneurysm Abdominal
In brief
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.
Key facts
- Study ID
- NCT05141123
- Run by
- IRCCS San Raffaele
- People needed
- 741
- Starts
- 2022-10-30
- Expected to finish
- 2023-04-20
- Last updated by the study team
- 2023-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- UMass Memorial Center for Complex Aortic Disease — Worcester, Massachusetts, United States
- Southwestern Medical Center, Dallas — Dallas, Texas, United States
- McGovern Medical School — Houston, Texas, United States
- University of Washington Seatle — Seattle, Washington, United States
- Copenhagen Aortic Center — Copenhagen, Denmark
- Centre Hospitalier Universitaire — Lille, France
- Timone Hospital Marseille — Marseille, France
- Centre Hospitalier Universitaire de Nantes — Nantes, France
- Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay — Paris, France
- Hamburg Aortic Center — Hamburg, Germany
- Ludwig Maximilian University Hospital — Munich, Germany
- St. Franziskus Hospital — Münster, Germany
- Policlinico S. Orsola Malpighi — Bologna, Italy
- Hospital Doctor Peset — Valencia, Spain
- Vascular Center Malmö, Skåne University Hospital — Malmö, Sweden
- Department of Surgical Sciences, Vascular Surgery, Uppsala University — Uppsala, Sweden
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom
- Kings College — London, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.