Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms: Study of Fenestrated and Branched Stent Grafts in the Treatment of Aortic Aneurysms
Overview
- Phase
- Not Applicable
- Sponsor
- Tara Mastracci
- Enrollment
- 1,000
- Primary Endpoint
- Longterm Aneurysm Related Mortality
Overview
Brief Summary
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
Detailed Description
This is a Global, multicenter, prospective, observational, non-randomized, single-arm, open clinical study will evaluate the long term (i.e. >5 years) safety and efficacy of complex endovascular repair
This study will enroll all patients treated with Fenestrated and Branched devices in Europe and Canada that follow all inclusion criteria and none of the exclusion criteria. The total duration of the study will be of approximately 7 years.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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.
- •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:
- •Patients whose imaging follow-up is impossible, i.e. patients who are not able to send their follow up CT scans or Duplex US
Outcomes
Primary Outcomes
Longterm Aneurysm Related Mortality
Time Frame: 7 years
Death attributed to aneurysm rupture
Secondary Outcomes
No secondary outcomes reported
Investigators
Tara Mastracci
Co-Investigator
Royal Free Hospital NHS Foundation Trust