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

Primary Purpose

Iliac Aneurysm

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ILIAC ENDOPROSTHESIS GORE EXCLUDER
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iliac Aneurysm

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GORE Excluder

Arm Description

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

Outcomes

Primary Outcome Measures

Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
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 maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
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 maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
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

Morbidity
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

Full Information

First Posted
July 27, 2017
Last Updated
August 24, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03312127
Brief Title
Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis
Acronym
HYPOGRAFT
Official Title
Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
End of inclusion period
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iliac Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GORE Excluder
Arm Type
Experimental
Arm Description
GORE Excluder Iliac Branch Endoprosthesis arm with 'ILIAC ENDOPROSTHESIS GORE EXCLUDER'
Intervention Type
Device
Intervention Name(s)
ILIAC ENDOPROSTHESIS GORE EXCLUDER
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
Description
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.
Time Frame
At the immediate post-operating follow-up visit
Title
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
Description
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.
Time Frame
at 3 months after surgery
Title
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
Description
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
Time Frame
at 12 months after surgery
Secondary Outcome Measure Information:
Title
Morbidity
Description
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
Time Frame
peri-operative, at short term (3 months), mean-term (12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre BOSSAVY, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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