Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position
NCT ID: NCT01710878
Last Updated: 2013-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2008-02-29
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary endpoint is the assessment of primary and secondary graft patency. The secondary endpoints were the assessment of adverse events and the assessment of triclosan and silver contents in the serum over the time.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intergard Synergy Graft
Intergard Synergy Graft
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intergard Synergy Graft
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maquet Cardiovascular
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Baptiste Ricco, MD
Role: PRINCIPAL_INVESTIGATOR
CHU La Milétrie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Frankfurt, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HR07-001
Identifier Type: -
Identifier Source: org_study_id