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OpenTrials
Completed

NCT Number: NCT01609270

CardioRoot Post-Marketing Surveillance Registry

Post-marketing surveillance registry of the CardioRoot graft.

Completed

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Key information

Conditions

Cardiovascular Surgical Procedure

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Olomouc, Olomouc, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CardioRoot graft

Device

prospective single arm multi-center study to evaluate CardioRoot grafts implanted in a thoracic position.

Primary outcomes

  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 outcomes

  1. Subject mortality rate

    Time frame: 30 days, 1 year

    Subject mortality rate will be followed out to one year post implantation.

Sponsors and collaborators

Lead sponsor

Maquet Cardiovascular

Industry

Registry information

Acronym: CardioRoot

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
May 31, 2012
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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