Prospective, Multicenter Study of the Second Generation Antimicrobial Graft in the Abdominal Position
Phase 4
- Conditions
- Aneurysmal Disease of the Abdominal AortaOcclusive Disease of the Abdominal Aorta
- Interventions
- Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)
- Registration Number
- NCT00824109
- Lead Sponsor
- Datascope Corp.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Study Second Generation Anti-Microbial bifurcated vascular graft (InterGard) Consecutive patients meeting the selection criteria
- Primary Outcome Measures
Name Time Method Graft patency at three years three years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU La Miletrie, 350 av. Jacques Coeur
🇫🇷86021 Poitiers, France