Aortic Aneurysm, Abdominal Clinical Trial
Official title:
InterGard Synergy Post-Marketing Surveillance Study
Verified date | November 2013 |
Source | Maquet Cardiovascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | May 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients requiring an InterGard Synergy Vascular Graft Exclusion Criteria: - Patients with contra-indications per InterGard Synergy Vascular Graft - Patients with current graft infection - Patients with a known allergy to collagen, triclosan or silver acetate - Patients who require urgent or emergent surgery |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Study Centers | Graz, Vienna | |
Germany | Study Centers | Frankfurt, Karlsruhe | |
Germany | Study Centers | Heidelberg, Hamburg, Hanau |
Lead Sponsor | Collaborator |
---|---|
Maquet Cardiovascular |
Austria, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Graft Patency and Complications | Patency will be assessed by color-coded duplex ultrasound up to 6 months post implantation. Complications including the occurrence of graft infections will be assessed up to post implantation. |
6 months | No |
Secondary | Mortality rate | Mortality rate will be assessed up to 6 months post implantation. | 6 months | No |
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