Status:

RECRUITING

Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

Lead Sponsor:

University Hospital, Lille

Collaborating Sponsors:

Santelys Association

Région Nord-Pas de Calais, France

Conditions:

Thoracic Aortic Aneurysm

Eligibility:

All Genders

45-80 years

Brief Summary

Thoracic aneurysm is a silent disease with a potential mid-term high risk of death or major complications. Few data are available on the real incidence of major complications in case of small and mode...

Eligibility Criteria

Inclusion

  • Documentation of an aortic root aneurysm \> 40 mm
  • Agreement to participate to a longitudinal study and available for a 5 years follow-up

Exclusion

  • Presence of comorbidities or pathology with a prognosis of less than 1 year
  • Personal or family history of genetically documented elastic tissue disease or patient meeting the GAND clinical criteria suggestive of Marfan disease
  • High-grade mitra-aortic valve disease, even if asymptomatic
  • Unbalanced hypertension ≥ 180/110 mmHg
  • Aneurysm (regardless of thoracic or abdominal location) ≥ 50 mm
  • Aneurysm (regardless of thoracic or abdominal location) with documented progression of more than 5 mm over one year
  • History of aortic surgery or endovascular intervention and history of type B aortic dissection of medical treatment
  • Renal insufficiency on dialysis, or GFR\< 30 ml/mn (CKD-EPI)

Key Trial Info

Start Date :

April 18 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2031

Estimated Enrollment :

320 Patients enrolled

Trial Details

Trial ID

NCT05395598

Start Date

April 18 2024

End Date

October 1 2031

Last Update

June 24 2024

Active Locations (1)

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CHU Lille

Lille, Please Choose..., France, 59037

Incidence of Major Complication in Case of Thoracic Aortic Aneurysm | DecenTrialz