InterGard Synergy Post-Marketing Surveillance Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maquet Cardiovascular
ClinicalTrials.gov Identifier:
NCT01698671
First received: October 1, 2012
Last updated: November 24, 2013
Last verified: November 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: InterGard Synergy Post-Marketing Surveillance Study

Resource links provided by NLM:


Further study details as provided by Maquet Cardiovascular:

Primary Outcome Measures:
  • Graft Patency and Complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maquet Cardiovascular
ClinicalTrials.gov Identifier: NCT01698671     History of Changes
Other Study ID Numbers: MCV00010173
Study First Received: October 1, 2012
Last Updated: November 24, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 18, 2014