InterGard Synergy Post-Marketing Surveillance Study

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

InterGard Synergy Post-Marketing Surveillance Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01698671
• Other study ID #: MCV00010173
• Status: Active, not recruiting
• Phase: N/A
• First received: October 1, 2012
• Last updated: November 24, 2013
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2013
• Source: Maquet Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.

Description:

Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Occlusive Disease of Artery of Lower Extremity

Intervention

Device:
• InterGard Synergy Vascular Graft

Locations

Country	Name	City	State
Austria	Study Centers	Graz, Vienna
Germany	Study Centers	Frankfurt, Karlsruhe
Germany	Study Centers	Heidelberg, Hamburg, Hanau

Sponsors (1)

Lead Sponsor	Collaborator
Maquet Cardiovascular

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

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