InterGard Synergy Post-Marketing Surveillance Study

November 24, 2013 updated by: Maquet Cardiovascular
The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Vienna, Austria
        • Study Centers
  • Germany
      • Frankfurt, Karlsruhe, Germany
        • Study Centers
      • Heidelberg, Hamburg, Hanau, Germany
        • Study Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: InterGard Synergy Vascular Graft
Device: InterGard Synergy Vascular Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft Patency and Complications
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 6 months
Mortality rate will be assessed up to 6 months post implantation.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maquet Cardiovascular

Investigators

  • Principal Investigator: Max Zegelman, MD, Krankenhaus Nordwest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 24, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCV00010173

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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