NCT01710878

Brief Summary

Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
2 countries

8 active sites

Status
completed

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

February 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

October 10, 2012

Last Update Submit

November 24, 2013

Conditions

Abdominal Aorta Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Primary Graft Patency

    Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months

    Up to 36 months

Secondary Outcomes (1)

  • Secondary endpoint - assessment of AEs

    Up to 36 months

Other Outcomes (1)

  • Secondary endpoint - levels of silver and triclosan

    Up to 30 days

Study Arms (1)

Intergard Synergy Graft

OTHER
Device: Intergard Synergy Graft

Interventions

Intergard Synergy GraftDEVICE
Intergard Synergy Graft

Eligibility Criteria

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

You may qualify if:

  • Patient aged 18-85 years
  • Patient presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and eligible for a revascularization with a bifurcated graft

You may not qualify if:

  • Patient treated as an emergency
  • Patient included in another investigation
  • Patient pregnant or lactating or woman of childbearing potential
  • Patient with a known allergy to the material device used (collagen, triclosan, silver)
  • Patient with previous aorto-iliac bypass or replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CHRU

Angers, France

Location

CHU Jean Minjoz

Besançon, France

Location

CHU Dupuytren

Limoges, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Hôpital G. et R. Laennec

Nantes, France

Location

Hôpital Pompidou

Paris, France

Location

CHU La Milétrie

Poitiers, France

Location

Krankenhaus Nordwest

Frankfurt, Germany

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Jean-Baptiste Ricco, MD

    CHU La Milétrie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 19, 2012

Study Start

February 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2012

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

DE(1)FR(7)