CardioRoot Post-Marketing Surveillance Registry
Post-marketing surveillance registry of the CardioRoot graft.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CardioRoot Post-Marketing Surveillance Registry|
- Graft complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]Complications will be assessed out to one year post implantation.
- Subject mortality rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]Subject mortality rate will be followed out to one year post implantation.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609270
|Contact: Pierluca Lombardi, M.D.||973 709 firstname.lastname@example.org|
|Olomouc, Czech Republic|
|Prague, Czech Republic|