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Clinical Trials/NCT01609270
NCT01609270
Completed
Not Applicable

CardioRoot Post-Marketing Surveillance Registry

Maquet Cardiovascular6 sites in 3 countries52 target enrollmentNovember 2013
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ConditionsCardiovascular Surgical Procedure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Surgical Procedure
Sponsor
Maquet Cardiovascular
Enrollment
52
Locations
6
Primary Endpoint
Graft complications
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
June 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Maquet Cardiovascular
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Graft complications

Time Frame: 1 year

Complications will be assessed out to one year post implantation.

Secondary Outcomes

  • Subject mortality rate(30 days, 1 year)

Study Sites (6)

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