Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms

Aortic Aneurysm Clinical Trial

— LoRETA  

Official title:

Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms: Study of Fenestrated and Branched Stent Grafts in the Treatment of Aortic Aneurysms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03499431
• Other study ID #: 001
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

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