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InterGard Synergy Post-Marketing Surveillance Study

NCT ID: NCT01698671

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-05-31

Brief Summary

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

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Detailed Description

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

Conditions

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Aortic Aneurysm, Abdominal Occlusive Disease of Artery of Lower Extremity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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InterGard Synergy Vascular Graft

Group Type OTHER

InterGard Synergy Vascular Graft

Intervention Type DEVICE

Interventions

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InterGard Synergy Vascular Graft

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maquet Cardiovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Max Zegelman, MD

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Nordwest

Locations

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Study Centers

Graz, Vienna, , Austria

Site Status

Study Centers

Frankfurt, Karlsruhe, , Germany

Site Status

Study Centers

Heidelberg, Hamburg, Hanau, , Germany

Site Status

Countries

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Austria Germany

Other Identifiers

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MCV00010173

Identifier Type: -

Identifier Source: org_study_id

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