Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Datascope Corp..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Datascope Corp.
ClinicalTrials.gov Identifier:
NCT00824109
First received: January 14, 2009
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Other Name: InterGard

  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: Philippe Bensimon, Director, Regulatory and Clinical Affairs, and Quality Assurance, Datascope InterVascular
ClinicalTrials.gov Identifier: NCT00824109     History of Changes
Other Study ID Numbers: HR07-001
Study First Received: January 14, 2009
Last Updated: December 2, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 May 16, 2013