Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-30

Study Completion Date

2023-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Aneurysm Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endovascular Thoracoabdominal Aneurysm Repair

Standard of care, treatment of thoracoabdominal aneurysms using endovascular techiniques.

Intervention Type DEVICE

Other Intervention Names

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Branched and Fenestrated Devices

Eligibility Criteria

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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.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No