Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position

Datascope Corp.1 site in 1 country60 target enrollmentJuly 2008

ConditionsAneurysmal Disease of the Abdominal Aorta Occlusive Disease of the Abdominal Aorta

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Aneurysmal Disease of the Abdominal Aorta
Sponsor: Datascope Corp.
Enrollment: 60
Locations: 1
Primary Endpoint: Graft patency at three years
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

September 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Datascope Corp.

Eligibility Criteria

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