CardioRoot Post-Marketing Surveillance Registry

Cardiovascular Surgical Procedure Clinical Trial

— CardioRoot  

Official title:

CardioRoot Post-Marketing Surveillance Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609270
• Other study ID #: MCV00008317
• Status: Completed
• Start date: November 2013
• Est. completion date: June 2017

Study information

• Verified date: September 2018
• Source: Maquet Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Post-marketing surveillance registry of the CardioRoot graft.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Surgical Procedure

Intervention

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

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc
Czechia	General University Hospital	Prague
Czechia	University Hospital Motol	Prague
France	Centre Hospitalier Universitaire (CHU) de Bordeaux	Bordeaux
Italy	Ospedale Manzoni di Lecco	Lecco
Italy	Ospedale Luigi Sacco	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Maquet Cardiovascular

Countries where clinical trial is conducted

Czechia,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft complications	Complications will be assessed out to one year post implantation.	30 days
Primary	Graft complications	Complications will be assessed out to one year post implantation.	1 year
Secondary	Subject mortality rate	Subject mortality rate will be followed out to one year post implantation.	30 days, 1 year