Text Size

CardioRoot Post-Marketing Surveillance Registry

This study is currently recruiting participants.
Verified April 2013 by Maquet Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Maquet Cardiovascular
ClinicalTrials.gov Identifier:
NCT01609270
First received: May 25, 2012
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

Post-marketing surveillance registry of the CardioRoot graft.


Condition Intervention
Thoracic Aortic Surgery
 Device: CardioRoot graft

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CardioRoot Post-Marketing Surveillance Registry

Further study details as provided by Maquet Cardiovascular:

Primary Outcome Measures:
  • Graft complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Complications will be assessed out to one year post implantation.


Secondary Outcome Measures:
  • Subject mortality rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Subject mortality rate will be followed out to one year post implantation.


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CardioRoot
All subjects receive the CardioRoot graft at baseline implant procedure.
 Device: CardioRoot graft
prospective single arm multi-center study to evaluate CardioRoot grafts implanted in a thoracic position.

Detailed Description:

Study objective is to monitor the performance and safety of CardioRoot vascular grafts implanted in a thoracic position. Patient survival rates will be monitored as well as immediate and long-term complications.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients requiring a CardioRoot graft as per the CardioRoot IFU

Exclusion Criteria:

  • patients with contra-indications per CardioRoot IFU
  • patients requiring consecutive aortic surgery
  • patients with coronary artery disease
  • patients who require urgent or emergent surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609270

Contacts
Contact: Pierluca Lombardi, M.D. 973 709 7570 pierluca.lombardi@maquet.com

Locations
Germany
University of Aachen Recruiting
Aachen, Germany
Contact: Andras Hoffman, M.D.     +1 49 241 8035266     anhoffman@ukaachen.de    
Sponsors and Collaborators
Maquet Cardiovascular
Investigators
Principal Investigator: Andras Hoffman, M.D University of Aachen, Germany
  More Information

No publications provided

Responsible Party: Maquet Cardiovascular
ClinicalTrials.gov Identifier: NCT01609270     History of Changes
Other Study ID Numbers: MCV00008317
Study First Received: May 25, 2012
Last Updated: April 25, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on June 17, 2013