Aneurysmal Disease of the Abdominal Aorta, Occlusive Disease of the Abdominal Aorta
Conditions
Keywords
Aneurysmal disease of the abdominal aorta, Occlusive disease of the abdominal aorta
Brief summary
The purpose of this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta.
Interventions
DEVICESecond Generation Anti-Microbial bifurcated vascular graft (InterGard)
treatment of patients with aorto-iliac occlusion,stenosis, or aneurysm
Sponsors
Datascope Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Is 18 - 85 years of age * Is presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and is eligible for a revascularization with a bifurcated graft * Is affiliated with a social welfare organization system * Is willing to participate in the clinical evaluation after signature of the informed consent * Is able to attend all follow up visits and diagnostics and laboratory exams required by the present protocol
Exclusion criteria
* Is treated as an emergency * Is included in another investigation * Is pregnant or lactating, or a woman of childbearing potential unwillint to use an effective form of contraception for the duration of the trial * Has a known allergy to the material device used * Has previous aorto-iliac bypass or replacement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft patency at three years | three years |
Countries
France
Contacts
Primary ContactJean-Baptiste Ricco, MD, Professor
Backup ContactPhilippe Bensimon, Director
Outcome results
None listed