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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03499431
Other study ID # 001
Secondary ID
Status Not yet recruiting
Phase
First received April 9, 2018
Last updated April 9, 2018
Start date April 30, 2018
Est. completion date March 2023

Study information

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]

Clinical Trial 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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Endovascular Thoracoabdominal Aneurysm Repair
Standard of care, treatment of thoracoabdominal aneurysms using endovascular techiniques.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Tara Mastracci Skane University Hospital, University Hospital, Lille

Outcome

Type Measure Description Time frame Safety issue
Primary Longterm Aneurysm Related Mortality Death attributed to aneurysm rupture 7 years
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