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Status unknownNCT00824109Updated Dec 3, 2010

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

A Phase 4 interventional study of Second Generation Anti-Microbial bifurcated vascular graft (InterGard) in Aneurysmal Disease of the Abdominal Aorta and Occlusive Disease of the Abdominal Aorta, sponsored by Datascope Corp.. Status unknown at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-12-03.

Sponsored by Datascope Corp. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aneurysmal Disease of the Abdominal Aorta
  • Occlusive Disease of the Abdominal Aorta

Keywords

  • Aneurysmal disease of the abdominal aorta
  • Occlusive disease of the abdominal aorta
03

In context

Lead sponsor

Datascope Corp. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    Single Arm Study

    Consecutive patients meeting the selection criteria

    Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)

Interventions

  • DeviceSecond Generation Anti-Microbial bifurcated vascular graft (InterGard)

    treatment of patients with aorto-iliac occlusion,stenosis, or aneurysm

    Also known as: InterGard

06

What researchers measure

Primary outcomes

  1. Graft patency at three years

    Time frame: three years

07

Study locations

1 of 1 sites recruiting
  • CHU La Miletrie, 350 av. Jacques Coeur
    86021 Poitiers, France
    Recruiting
    • Jean-Baptiste Ricco, MD · Contact
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008, a primary completion of Sep 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2009
First posted
Jan 16, 2009
Start
Jul 2008
Primary completionEst.
Sep 2011
CompletionEst.
Sep 2011
Last update
Dec 3, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00824109
Lead sponsor
Datascope Corp.
First posted
Jan 16, 2009
Start date
Jul 2008
Primary completion
Sep 2011 (estimated)
Completion
Sep 2011 (estimated)
Last update
Dec 3, 2010

Study contacts

Jean-Baptiste Ricco, MD, Professor
Contact
j.b.ricco@chu-poitiers.fr
00 33 5494438 46
Philippe Bensimon, Director
Contact
philippe.bensimon@datascope.com
011 33 44 208 7784
Jean-Baptiste Ricco, MD
principal investigator · Vascular Surgery Dept, CHU La Miletrie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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Datascope Corp.

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