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InterGard Synergy Post-Marketing Surveillance Study

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
InterGard Synergy Vascular Graft
Sponsored by
Maquet Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Study Centers
  • Study Centers
  • Study Centers

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

InterGard Synergy Vascular Graft

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 1, 2012
Last Updated
November 24, 2013
Sponsor
Maquet Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT01698671
Brief Title
InterGard Synergy Post-Marketing Surveillance Study
Official Title
InterGard Synergy Post-Marketing Surveillance Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maquet Cardiovascular

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal, Occlusive Disease of Artery of Lower Extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
InterGard Synergy Vascular Graft
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
InterGard Synergy Vascular Graft
Primary Outcome Measure Information:
Title
Graft Patency and Complications
Description
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 Outcome Measure Information:
Title
Mortality rate
Description
Mortality rate will be assessed up to 6 months post implantation.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Zegelman, MD
Organizational Affiliation
Krankenhaus Nordwest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Study Centers
City
Graz, Vienna
Country
Austria
Facility Name
Study Centers
City
Frankfurt, Karlsruhe
Country
Germany
Facility Name
Study Centers
City
Heidelberg, Hamburg, Hanau
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

InterGard Synergy Post-Marketing Surveillance Study

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