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

NCT03312127 | Terminated DMC

• 1 other identifier: 14 7427 15
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Iliac Aneurysm

Outcome Measures

Primary Outcomes (3)

• 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 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 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 Outcomes (1)

• Morbidity

  peri-operative, at short term (3 months), mean-term (12 months)

Study Arms (1)

GORE Excluder

EXPERIMENTAL

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

Device: ILIAC ENDOPROSTHESIS GORE EXCLUDER

Interventions

ILIAC ENDOPROSTHESIS GORE EXCLUDER 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.

GORE Excluder

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Iliac Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean-Pierre BOSSAVY, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: October 17, 2017
• Study Start: August 1, 2017
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: August 26, 2020

Record last verified: 2020-08

Locations

FR (1)