CardioRoot Post-Marketing Surveillance Registry

This study is currently recruiting participants.
Verified March 2014 by Maquet Cardiovascular
Information provided by (Responsible Party):
Maquet Cardiovascular Identifier:
First received: May 25, 2012
Last updated: March 29, 2014
Last verified: March 2014

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: June 2015
Estimated Primary Completion Date: May 2015 (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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01609270

Contact: Pierluca Lombardi, M.D. 973 709 7570

Czech Republic
Olomouc, Czech Republic
Prague, Czech Republic
Bordeaux, France
Lecco, Italy
Sponsors and Collaborators
Maquet Cardiovascular
  More Information

No publications provided

Responsible Party: Maquet Cardiovascular Identifier: NCT01609270     History of Changes
Other Study ID Numbers: MCV00008317
Study First Received: May 25, 2012
Last Updated: March 29, 2014
Health Authority: Czech Republic: Ethics Committee
France: Committee for the Protection of Personnes
Germany: Ethics Commission processed this record on April 17, 2014