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CardioRoot Post-Marketing Surveillance Registry (CardioRoot)

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ClinicalTrials.gov Identifier: NCT01609270
Recruitment Status : Unknown
Verified April 2015 by Maquet Cardiovascular.
Recruitment status was:  Recruiting
First Posted : May 31, 2012
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
Maquet Cardiovascular

Brief Summary:
Post-marketing surveillance registry of the CardioRoot graft.

Condition or disease Intervention/treatment Phase
Cardiovascular Surgical Procedure Device: CardioRoot graft Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CardioRoot Post-Marketing Surveillance Registry
Study Start Date : October 2012
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : July 2016

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Graft complications [ Time Frame: 1 year ]
    Complications will be assessed out to one year post implantation.


Secondary Outcome Measures :
  1. Subject mortality rate [ Time Frame: 1 year ]
    Subject mortality rate will be followed out to one year post implantation.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609270


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

Locations
Czech Republic
University Hospital Recruiting
Olomouc, Czech Republic
General University Hospital Recruiting
Prague, Czech Republic
IKEM Recruiting
Prague, Czech Republic
Motol Hospital Recruiting
Prague, Czech Republic
France
CHU de Bordeaux Recruiting
Bordeaux, France
Italy
Azienda Ospedaliera Recruiting
Lecco, Italy
Ospedale Luigi Sacco Recruiting
Milano, Italy
Casa Di Cura Villa Verde - Cardiochirurgica Recruiting
Taranto, Italy
Sponsors and Collaborators
Maquet Cardiovascular

Responsible Party: Maquet Cardiovascular
ClinicalTrials.gov Identifier: NCT01609270     History of Changes
Other Study ID Numbers: MCV00008317
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015