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

Toulouse University Hospital

Status: Terminated

Conditions: Iliac Aneurysm

Treatments: Device: ILIAC ENDOPROSTHESIS GORE EXCLUDER

Study type: Interventional

Funder types: Other

Identifiers

NCT03312127

14 7427 15

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

GORE Excluder

Experimental group

Description:

GORE Excluder Iliac Branch Endoprosthesis arm with 'ILIAC ENDOPROSTHESIS GORE EXCLUDER'

Treatment:

Device: ILIAC ENDOPROSTHESIS GORE EXCLUDER