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

This study is currently recruiting participants.

Verified by Datascope Corp., February 2010

First Received: January 14, 2009 Last Updated: February 5, 2010 History of Changes

Sponsor:	Datascope Corp.
Information provided by:	Datascope Corp.
ClinicalTrials.gov Identifier:	NCT00824109

Purpose

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.

Condition	Intervention	Phase
Aneurysmal Disease of the Abdominal Aorta Occlusive Disease of the Abdominal Aorta	Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position

Further study details as provided by Datascope Corp.:

Primary Outcome Measures:

Graft patency at three years [ Time Frame: three years ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824109

Contacts

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

Locations

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

Sponsors and Collaborators

Datascope Corp.

Investigators

Principal Investigator:

Jean-Baptiste Ricco, MD

Vascular Surgery Dept, CHU La Miletrie

More Information

No publications provided

Responsible Party:	Datascope InterVascular ( Philippe Bensimon, Director, Regulatory and Clinical Affairs, and Quality Assurance )
Study ID Numbers:	HR07-001
Study First Received:	January 14, 2009
Last Updated:	February 5, 2010
ClinicalTrials.gov Identifier:	NCT00824109 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Datascope Corp.:

Aneurysmal disease of the abdominal aorta
Occlusive disease of the abdominal aorta

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010