Informations générales (source: ClinicalTrials.gov)

NCT00824109 Statut inconnu
Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position
Interventional
Phase 4
Datascope Corp. (Voir sur ClinicalTrials)
juillet 2008
septembre 2011
29 juin 2024
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.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU La Miletrie, 350 av. Jacques Coeur - 86021 Poitiers - France Jean-Baptiste Ricco, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
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


- 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