CardioRoot Post-Marketing Surveillance Registry (CardioRoot)

September 13, 2018 updated by: Maquet Cardiovascular
Post-marketing surveillance registry of the CardioRoot graft.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with aneurysmal and occlusive disease of the thoracic aorta treated with a CARDIOROOT vascular graft.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft complications
Time Frame: 30 days
Complications will be assessed out to one year post implantation.
30 days
Graft complications
Time Frame: 1 year
Complications will be assessed out to one year post implantation.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maquet Cardiovascular

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2013

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (ESTIMATE)

May 31, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MCV00008317

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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