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

Iliac Aneurysm Clinical Trial

— HYPOGRAFT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03312127
• Other study ID #: 14 7427 15
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 26, 2018

Study information

• Verified date: August 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 26, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Iliac Aneurysm

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the immediate post-operating follow-up visit
Primary	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.	at 3 months after surgery
Primary	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	at 12 months after surgery
Secondary	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	peri-operative, at short term (3 months), mean-term (12 months)