NCT01609270

Brief Summary

Post-marketing surveillance registry of the CardioRoot graft.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

2.6 years

First QC Date

May 25, 2012

Last Update Submit

September 13, 2018

Conditions

Cardiovascular Surgical Procedure

Outcome Measures

Primary Outcomes (2)

  • Graft complications

    Complications will be assessed out to one year post implantation.

    30 days

  • Graft complications

    Complications will be assessed out to one year post implantation.

    1 year

Secondary Outcomes (1)

  • Subject mortality rate

    30 days, 1 year

Study Arms (1)

CardioRoot

All subjects receive the CardioRoot graft at baseline implant procedure.

Device: CardioRoot graft

Interventions

CardioRoot graftDEVICE

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

CardioRoot

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • patients with contra-indications per CardioRoot IFU
  • patients requiring consecutive aortic surgery
  • patients with coronary artery disease
  • patients who require urgent or emergent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital Olomouc

Olomouc, 775 20, Czechia

Location

General University Hospital

Prague, 128 08, Czechia

Location

University Hospital Motol

Prague, 150 06, Czechia

Location

Centre Hospitalier Universitaire (CHU) de Bordeaux

Bordeaux, 33404, France

Location

Ospedale Manzoni di Lecco

Lecco, 23900, Italy

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Related Publications (1)

  • Tasca G, Lindner J, Barandon L, Santavy P, Antona C, Burkert J, Gamba A. Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study. J Cardiothorac Surg. 2019 May 21;14(1):94. doi: 10.1186/s13019-019-0914-y.

    PMID: 31113456DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2012

First Posted

May 31, 2012

Study Start

November 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2017

Last Updated

September 17, 2018

Record last verified: 2018-09

Locations

CZ(3)FR(1)IT(2)