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

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ClinicalTrials.gov Identifier: NCT03312127
Recruitment Status : Terminated (End of inclusion period)
First Posted : October 17, 2017
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Iliac Aneurysm Device: ILIAC ENDOPROSTHESIS GORE EXCLUDER Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : July 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: GORE Excluder
GORE Excluder Iliac Branch Endoprosthesis arm with 'ILIAC ENDOPROSTHESIS GORE EXCLUDER'
Device: 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.




Primary Outcome Measures :
  1. Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion) [ Time Frame: At the immediate post-operating follow-up visit ]

    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.


  2. Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion) [ Time Frame: at 3 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.


  3. Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion) [ Time Frame: 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 :
  1. Morbidity [ Time Frame: 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312127


Locations
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France
University Hospital Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Jean-Pierre BOSSAVY, MD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03312127    
Other Study ID Numbers: 14 7427 15
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases