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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-07-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Iliac Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GORE Excluder

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

Group Type EXPERIMENTAL

ILIAC ENDOPROSTHESIS GORE EXCLUDER

Intervention Type DEVICE

Set up of GORE ® Excluder Iliac Branch Endoprosthesis in endovascular barring of complex aneurysms without distal neck. In the immediate post-operating follow-up visit and at the 3 months visit and the 12 months visit after surgery, an ultra-sound scan, a tomodensitometric exam and a walking test on a treadmill with oximetric gluteal region exploration will systematically be performed.

Interventions

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ILIAC ENDOPROSTHESIS GORE EXCLUDER

Set up of GORE ® Excluder Iliac Branch Endoprosthesis in endovascular barring of complex aneurysms without distal neck. In the immediate post-operating follow-up visit and at the 3 months visit and the 12 months visit after surgery, an ultra-sound scan, a tomodensitometric exam and a walking test on a treadmill with oximetric gluteal region exploration will systematically be performed.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No