Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms

NCT03499431 | Unknown DMC

• 1 other identifier: 001
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Aneurysm; Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Longterm Aneurysm Related Mortality

  Death attributed to aneurysm rupture

  7 years

Interventions

Endovascular Thoracoabdominal Aneurysm Repair DEVICE

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

Also known as: Branched and Fenestrated Devices

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing complex EVAR at study sites.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tara Mastracci: lead
• University Hospital, Lille: collaborator
• Skane University Hospital: collaborator

MeSH Terms

Conditions

Aneurysm; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: April 30, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2023
• Last Updated: April 17, 2018

Record last verified: 2018-04