Prospective, Multicenter Study of the Second Generation Antimicrobial Graft in the Abdominal Position

Datascope

Status and phase: Unknown; Phase 4

Conditions: Occlusive Disease of the Abdominal Aorta; Aneurysmal Disease of the Abdominal Aorta

Treatments: Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00824109

HR07-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Single Arm Study

Other group

Description:

Consecutive patients meeting the selection criteria

Treatment:

Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)