Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms

• Conditions: Aortic Aneurysm; Aneurysm

• Registration Number: NCT03499431
• Lead Sponsor: Tara Mastracci

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 Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-09
• Last Update Submitted: 2018-04-09
• Study First Posted: 2018-04-17
• Last Update Posted: 2018-04-17
• Study Start: 2018-04-30
• Primary Completion: 2021-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Longterm Aneurysm Related Mortality	7 years	Death attributed to aneurysm rupture