CardioRoot Post-Marketing Surveillance Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01609270

Acronym

CardioRoot

Enrollment

Registered

2012-05-31

Start date

2013-11-30

Completion date

2017-06-30

Last updated

2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Surgical Procedure

Brief summary

Post-marketing surveillance registry of the 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.

Interventions

DEVICECardioRoot graft

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Graft complications	30 days	Complications will be assessed out to one year post implantation.

Secondary

Measure	Time frame	Description
Subject mortality rate	30 days, 1 year	Subject mortality rate will be followed out to one year post implantation.

Countries

Czechia, France, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026