NCT00824109

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

3.2 years

First QC Date

January 14, 2009

Last Update Submit

December 2, 2010

Conditions

Aneurysmal Disease of the Abdominal AortaOcclusive Disease of the Abdominal Aorta

Keywords

Aneurysmal disease of the abdominal aortaOcclusive disease of the abdominal aorta

Outcome Measures

Primary Outcomes (1)

  • Graft patency at three years

    three years

Study Arms (1)

Single Arm Study

OTHER

Consecutive patients meeting the selection criteria

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

Interventions

Second Generation Anti-Microbial bifurcated vascular graft (InterGard)DEVICE

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

Also known as: InterGard
Single Arm Study

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU La Miletrie, 350 av. Jacques Coeur

86021 Poitiers, France

RECRUITING

Study Officials

  • Jean-Baptiste Ricco, MD

    Vascular Surgery Dept, CHU La Miletrie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Baptiste Ricco, MD, Professor

CONTACT

00 33 5494438 46j.b.ricco@chu-poitiers.fr

Philippe Bensimon, Director

CONTACT

011 33 44 208 7784philippe.bensimon@datascope.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 16, 2009

Study Start

July 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

FR(1)