BioFreedom Pharmacokinetic Study

Status Completed

Clinical Trial Summary

Clinical Trial Description

The purpose of this pharmacokinetic (PK) study is to characterize the maximum concentration (Cmax) and time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus in a cohort of coronary artery disease (CAD) patients following implantation of BioFreedomTM SS stent.

The study will include up to 20 CAD patients following implantation of the commercially available BioFreedomTM SS stent in a single Spanish center. Venous blood samples will be taken up to 72 hours after implantation. Whole blood concentrations of Biolimus A9TM and its active metabolites sirolimus and everolimus will be determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay. Mean, median and range of PK variables (Cmax, Tmax, and AUC) together with a Summary Statistics table will be generated as part of the PK analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03365492
Study type	Interventional
Source	Biosensors Europe SA
Contact
Status	Completed
Phase	N/A
Start date	March 12, 2018
Completion date	June 30, 2018

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