Aortic Aneurysm Clinical Trial
— LoRETAOfficial title:
Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms: Study of Fenestrated and Branched Stent Grafts in the Treatment of Aortic Aneurysms
Verified date | April 2018 |
Source | Royal Free Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The purpose of this study is to evaluate the long-term safety and performance of complex endovascular aneurysm repair by inclusion in a longitudinal registry
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | March 2023 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Patient eligibility for enrolment shall be based on known information at the time of the procedure. Information obtained at a later date may contradict these criteria, but this will not be considered a deviation of the Study Plan. Inclusion criteria A patient is deemed suitable for inclusion in the study if the patient meets both of the following criteria: 1. Patient requires endovascular repair of a thoracic, thoraco-abdominal or abdominal aortic or aorto-iliac aneurysm having morphology suitable for endovascular repair with complex endograft. 2. Patients (or their legal representative for minor patients) who do not object to (oral non-objection declaration, and signed consent form) collection and transmission of his/her data. Exclusion Criteria: - Patients are excluded from enrolment into the study if any of the following are true: 1. Patients whose imaging follow-up is impossible, i.e. patients who are not able to send their follow up CT scans or Duplex US |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tara Mastracci | Skane University Hospital, University Hospital, Lille |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Longterm Aneurysm Related Mortality | Death attributed to aneurysm rupture | 7 years |
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