CardioRoot Post-Marketing Surveillance Registry
Completed
- Conditions
- Cardiovascular Surgical Procedure
- Interventions
- Device: CardioRoot graft
- Registration Number
- NCT01609270
- Lead Sponsor
- Maquet Cardiovascular
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CardioRoot CardioRoot graft All subjects receive the CardioRoot graft at baseline implant procedure.
- Primary Outcome Measures
Name Time Method Graft complications 1 year Complications will be assessed out to one year post implantation.
- Secondary Outcome Measures
Name Time Method Subject mortality rate 30 days, 1 year Subject mortality rate will be followed out to one year post implantation.
Trial Locations
- Locations (6)
General University Hospital
🇨🇿Prague, Czechia
University Hospital Motol
🇨🇿Prague, Czechia
Centre Hospitalier Universitaire (CHU) de Bordeaux
🇫🇷Bordeaux, France
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Ospedale Manzoni di Lecco
🇮🇹Lecco, Italy
Ospedale Luigi Sacco
🇮🇹Milano, Italy