LoRETA: Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms

Sponsor

Tara Mastracci (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03499431

Collaborator

University Hospital, Lille (Other), Skane University Hospital (Other)

1,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aneurysm Aortic Aneurysm	Device: Endovascular Thoracoabdominal Aneurysm Repair

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 30, 2018

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2023

Outcome Measures

Primary Outcome Measures

Longterm Aneurysm Related Mortality [7 years]
Death attributed to aneurysm rupture

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tara Mastracci
University Hospital, Lille
Skane University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tara Mastracci, Co-Investigator, Royal Free Hospital NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT03499431

Other Study ID Numbers:

First Posted:

Apr 17, 2018

Last Update Posted:

Apr 17, 2018

Last Verified:

Apr 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aneurysm

Aortic Aneurysm

Study Results

No Results Posted as of Apr 17, 2018