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InterGard Synergy Post-Marketing Surveillance Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Maquet Cardiovascular.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01698671
First Posted: October 3, 2012
Last Update Posted: November 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maquet Cardiovascular
  Purpose
The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.

Condition Intervention
Aortic Aneurysm, Abdominal Occlusive Disease of Artery of Lower Extremity Device: InterGard Synergy Vascular Graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: InterGard Synergy Post-Marketing Surveillance Study

Further study details as provided by Maquet Cardiovascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Mortality rate [ Time Frame: 6 months ]
    Mortality rate will be assessed up to 6 months post implantation.


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: May 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
InterGard Synergy Vascular Graft Device: InterGard Synergy Vascular Graft

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698671


Locations
Austria
Study Centers
Graz, Vienna, Austria
Germany
Study Centers
Frankfurt, Karlsruhe, Germany
Study Centers
Heidelberg, Hamburg, Hanau, Germany
Sponsors and Collaborators
Maquet Cardiovascular
Investigators
Principal Investigator: Max Zegelman, MD Krankenhaus Nordwest
  More Information

Responsible Party: Maquet Cardiovascular
ClinicalTrials.gov Identifier: NCT01698671     History of Changes
Other Study ID Numbers: MCV00010173
First Submitted: October 1, 2012
First Posted: October 3, 2012
Last Update Posted: November 26, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases