- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03312127
Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis (HYPOGRAFT)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31059
- University Hospital Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GORE Excluder
GORE Excluder Iliac Branch Endoprosthesis arm with '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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
At the immediate post-operating follow-up visit
|
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. |
at 3 months after surgery
|
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 |
at 12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morbidity
Time Frame: peri-operative, at short term (3 months), mean-term (12 months)
|
Evaluation of the morbidity:
|
peri-operative, at short term (3 months), mean-term (12 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Pierre BOSSAVY, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14 7427 15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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