InterGard Synergy Post-Marketing Surveillance Study

N/AUnknownNCT01698671

Maquet Cardiovascular50 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Aneurysm, Abdominal Occlusive Disease of Artery of Lower Extremity

Interventions

InterGard Synergy Vascular GraftDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (3)

Study Centers

Graz, Vienna, Austria

Study Centers

Frankfurt, Karlsruhe, Germany

Study Centers

Heidelberg, Hamburg, Hanau, Germany

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Mortality rate

Mortality rate will be assessed up to 6 months post implantation.

Time frame: 6 months

Data from ClinicalTrials.gov

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