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

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

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 Overview

• Status: Unknown
• Conditions: Aneurysmal Disease of the Abdominal Aorta; Occlusive Disease of the Abdominal Aorta
• Intervention / Treatment: Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jean-Baptiste Ricco, MD, Professor; Phone Number: 00 33 5494438 46; Email: j.b.ricco@chu-poitiers.fr
• Study Contact Backup: Name: Philippe Bensimon, Director; Phone Number: 011 33 44 208 7784; Email: philippe.bensimon@datascope.com

Study Locations

• France
  • 86021 Poitiers, France
    • Recruiting
    • CHU La Miletrie, 350 av. Jacques Coeur
    • Contact: Jean-Baptiste Ricco, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm Study; Consecutive patients meeting the selection criteria	Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard); treatment of patients with aorto-iliac occlusion,stenosis, or aneurysm; Other Names: InterGard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Graft patency at three years	three years

Collaborators and Investigators

• Sponsor: Datascope Corp.
• Investigators: Principal Investigator: Jean-Baptiste Ricco, MD, Vascular Surgery Dept, CHU La Miletrie

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: January 14, 2009
• First Submitted That Met QC Criteria: January 15, 2009
• First Posted (Estimate): January 16, 2009

Study Record Updates

• Last Update Posted (Estimate): December 3, 2010
• Last Update Submitted That Met QC Criteria: December 2, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Aneurysmal disease of the abdominal aorta; Occlusive disease of the abdominal aorta
• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: HR07-001