Status:
UNKNOWN
Prospective, Multicenter Study of the Second Generation Antimicrobial Graft in the Abdominal Position
Lead Sponsor:
Datascope Corp.
Conditions:
Aneurysmal Disease of the Abdominal Aorta
Occlusive Disease of the Abdominal Aorta
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00824109
Start Date
July 1 2008
End Date
September 1 2011
Last Update
December 3 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU La Miletrie, 350 av. Jacques Coeur
86021 Poitiers, France