Prospective, Multicenter Study of the Second Generation Antimicrobial Graft in the Abdominal Position
NCT ID: NCT00824109
Last Updated: 2010-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2008-07-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm Study
Consecutive patients meeting the selection criteria
Second Generation Anti-Microbial bifurcated vascular graft (InterGard)
treatment of patients with aorto-iliac occlusion,stenosis, or aneurysm
Interventions
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Second Generation Anti-Microbial bifurcated vascular graft (InterGard)
treatment of patients with aorto-iliac occlusion,stenosis, or aneurysm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
No
Sponsors
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Datascope Corp.
INDUSTRY
Responsible Party
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Datascope InterVascular
Principal Investigators
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Jean-Baptiste Ricco, MD
Role: PRINCIPAL_INVESTIGATOR
Vascular Surgery Dept, CHU La Miletrie
Locations
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CHU La Miletrie, 350 av. Jacques Coeur
86021 Poitiers, , France
Countries
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Central Contacts
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Facility Contacts
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Jean-Baptiste Ricco, MD
Role: primary
Other Identifiers
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HR07-001
Identifier Type: -
Identifier Source: org_study_id