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CardioRoot Post-Marketing Surveillance Registry (CardioRoot)

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ClinicalTrials.gov Identifier: NCT01609270
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Maquet Cardiovascular

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

Condition or disease Intervention/treatment
Cardiovascular Surgical Procedure Device: CardioRoot graft

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 : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CardioRoot Post-Marketing Surveillance Registry
Actual Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2017

Group/Cohort Intervention/treatment
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: 30 days ]
    Complications will be assessed out to one year post implantation.

  2. 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: 30 days, 1 year ]
    Subject mortality rate will be followed out to one year post implantation.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with aneurysmal and occlusive disease of the thoracic aorta treated with a CARDIOROOT vascular graft.
Criteria

Inclusion Criteria:

  • patients requiring a CardioRoot graft as per the CardioRoot Instructions for Use (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


Locations
Czechia
University Hospital Olomouc
Olomouc, Czechia, 775 20
General University Hospital
Prague, Czechia, 128 08
University Hospital Motol
Prague, Czechia, 150 06
France
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, France, 33404
Italy
Ospedale Manzoni di Lecco
Lecco, Italy, 23900
Ospedale Luigi Sacco
Milano, Italy, 20157
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: September 17, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No