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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

January 14, 2009
December 2, 2010
July 2008
September 2011   (final data collection date for primary outcome measure)
Graft patency at three years [ Time Frame: three years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00824109 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aneurysmal Disease of the Abdominal Aorta
  • Occlusive Disease of the Abdominal Aorta
Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)
treatment of patients with aorto-iliac occlusion,stenosis, or aneurysm
Other Name: InterGard
Single Arm Study
Consecutive patients meeting the selection criteria
Intervention: Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
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
France
 
NCT00824109
HR07-001
No
Philippe Bensimon, Director, Regulatory and Clinical Affairs, and Quality Assurance, Datascope InterVascular
Datascope Corp.
Not Provided
Principal Investigator: Jean-Baptiste Ricco, MD Vascular Surgery Dept, CHU La Miletrie
Datascope Corp.
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP