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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
Information provided by (Responsible Party):
Maquet Cardiovascular Identifier:
First received: October 1, 2012
Last updated: November 24, 2013
Last verified: November 2013
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01698671

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

Responsible Party: Maquet Cardiovascular Identifier: NCT01698671     History of Changes
Other Study ID Numbers: MCV00010173
Study First Received: October 1, 2012
Last Updated: November 24, 2013

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on August 23, 2017