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CardioRoot Post-Marketing Surveillance Registry (CardioRoot)

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 April 2015 by Maquet Cardiovascular.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609270
First Posted: May 31, 2012
Last Update Posted: April 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maquet Cardiovascular
May 25, 2012
May 31, 2012
April 23, 2015
October 2012
April 2016   (Final data collection date for primary outcome measure)
Graft complications [ Time Frame: 1 year ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cardiovascular Surgical Procedure
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.
 
Unknown status
50
July 2016
April 2016   (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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Italy
Germany
 
NCT01609270
MCV00008317
No
Not Provided
Not Provided
Maquet Cardiovascular
Maquet Cardiovascular
Not Provided
Not Provided
Maquet Cardiovascular
April 2015

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