InterGard Synergy Post-Marketing Surveillance Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01698671

Enrollment

Registered

2012-10-03

Start date

2012-10-31

Completion date

2014-05-31

Last updated

2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

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

Interventions

DEVICEInterGard Synergy Vascular Graft

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Graft Patency and Complications	6 months	* 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.

Secondary

Measure	Time frame	Description
Mortality rate	6 months	Mortality rate will be assessed up to 6 months post implantation.

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026