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CardioRoot Post-Marketing Surveillance Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Maquet Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Maquet Cardiovascular
ClinicalTrials.gov Identifier:
NCT01609270
First received: May 25, 2012
Last updated: October 20, 2014
Last verified: October 2014

May 25, 2012
October 20, 2014
October 2012
December 2015   (final data collection date for primary outcome measure)
Graft complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complications will be assessed out to one year post implantation.
Same as current
Complete list of historical versions of study NCT01609270 on ClinicalTrials.gov Archive Site
Subject mortality rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Subject mortality rate will be followed out to one year post implantation.
Same as current
Not Provided
Not Provided
 
CardioRoot Post-Marketing Surveillance Registry
CardioRoot Post-Marketing Surveillance Registry

Post-marketing surveillance registry of the CardioRoot graft.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thoracic Aortic Surgery
Device: CardioRoot graft
prospective single arm multi-center study to evaluate CardioRoot grafts implanted in a thoracic position.
Experimental: CardioRoot
All subjects receive the CardioRoot graft at baseline implant procedure.
Intervention: Device: CardioRoot graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Pierluca Lombardi, M.D. 973 709 7570 pierluca.lombardi@maquet.com
Czech Republic,   France,   Italy
 
NCT01609270
MCV00008317
No
Maquet Cardiovascular
Maquet Cardiovascular
Not Provided
Not Provided
Maquet Cardiovascular
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP