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

Not Applicable

Terminated

• Conditions: Iliac Aneurysm
• Interventions: Device: ILIAC ENDOPROSTHESIS GORE EXCLUDER

• Registration Number: NCT03312127
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-27
• Study Start: 2017-08-01
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GORE Excluder	ILIAC ENDOPROSTHESIS GORE EXCLUDER	GORE Excluder Iliac Branch Endoprosthesis arm with 'ILIAC ENDOPROSTHESIS GORE EXCLUDER'

Primary Outcome Measures

Name	Time	Method
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)	at 12 months after surgery	Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry.; Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis.; Primary permeability will be considered non-maintained at 1 year if a stenosis \>70% or a thrombosis of the hypogastric branch is observed by ultra-sound scan at a follow-up visit during the first year after surgery or at a ultra-sound scan exam motivated by pelvic ischemia clinical signs

Secondary Outcome Measures

Name	Time	Method
Morbidity	peri-operative, at short term (3 months), mean-term (12 months)	Evaluation of the morbidity: * Minor events (no revision surgery needed): * General: pulmonary, cardiologic, renal; * Local: hematoma, false aneurysm, Impaired wound healing; * Major events (revision surgery needed): * Endoleak; * Thrombosis; * Rupture

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France