Status:

TERMINATED

Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis

Lead Sponsor:

University Hospital, Toulouse

Conditions:

Iliac Aneurysm

Eligibility:

All Genders

50+ years

Phase:

NA

Brief Summary

The aim of this project is to demonstrate the benefit of the use of aortic iliac branch endoprosthesis in the iliac aneurysms and to avoid the classic complications.

Eligibility Criteria

Inclusion

  • High surgical risk:
  • Comorbidity cardiopulmonary
  • Renal insufficiency
  • Hostile abdomen including ascites or portal hypertension
  • Anatomic criteria:
  • Primitive iliac aneurysm superior to 25 mm without collar
  • Primitive iliac length superior to 40 mm
  • Primitive iliac distal diameter superior to 14 mm
  • Presence of internal iliac collar
  • Affiliation to a social security system

Exclusion

  • Patient without surgical risk
  • Non-respect of the Anatomic criteria
  • Patient with known allergy to the materials of the device
  • Patient with systemic infection
  • Patient with severe renal insufficiency
  • Patient unable to complete the oximetry test
  • Persons under legal protection

Key Trial Info

Start Date :

August 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 26 2018

Estimated Enrollment :

3 Patients enrolled

Trial Details

Trial ID

NCT03312127

Start Date

August 1 2017

End Date

July 26 2018

Last Update

August 26 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

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University Hospital Toulouse

Toulouse, France, 31059

Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis | DecenTrialz