NCT00824109UnknownPhase 4
Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Datascope Corp.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Graft patency at three years
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Single Arm Study
Other
Consecutive patients meeting the selection criteria
Intervention: Second Generation Anti-Microbial bifurcated vascular graft (InterGard) (Device)
Outcomes
Primary Outcomes
Graft patency at three years
Time Frame: three years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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