NCT01710878

Completed

Performance and Safety of a Second Generation Antimicrobial ...

Maquet Cardiovascular Source

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Other study identifiers

Sponsor study identifier

HR07-001

Study Type

interventional

Actual enrollment (reported)

60

Locations

2 countries

Sites

8

Timeline

Study Start

February 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2010

Actual (reported)

Study Completion

December 2012

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 60 participants
Study completion date: December 2012
Actual (reported)
Listed locations: 2 countries · 8 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2008
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)
First Submitted
October 10, 2012
Actual (reported)
First Posted
October 19, 2012
Actual (reported)
Study Completion
December 2012
Actual (reported)

Last Updated: November 26, 2013
Status Verified: November 2013
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Maquet Cardiovascular
Industrylead

Study Sites (8)

CHRU

Angers, France

CHU Jean Minjoz

Besançon, France

CHU Dupuytren

Limoges, France

Hôpital Edouard Herriot

Lyon, France

Hôpital G. et R. Laennec

Nantes, France

Hôpital Pompidou

Paris, France

CHU La Milétrie

Poitiers, France

Krankenhaus Nordwest

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

Enrollment

60 participants (actual enrollment reported by the registry).

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 2008

Date type not reported

This date has not been verified as actual or estimated.

NCT01189708

Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair

Not ApplicableTerminated

NCT00705718

Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

Not ApplicableCompleted

NCT01344239

Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair

Not ApplicableCompleted

NCT01092117

Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System

Not ApplicableCompleted

NCT00922454

Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft

Not ApplicableUnknown

NCT01652235

Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study

Not ApplicableCompleted

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.

Frankfurt, Germany

Primary Completion

December 2010

Actual (reported)

Study Completion

December 2012

Actual (reported)

Last Updated

November 26, 2013

Record last verified: 2013-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01710878
Data provider: ClinicalTrials.gov
Source updated: 2013-11-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:30 UTC

Locations

DE(1)FR(7)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (1)

Intergard Synergy Graft

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations