NCT03365492

BioFreedom Pharmacokinetic Study

BioFreedom PK Study in Patients With CAD Who Receive the BioFreedom™ Biolimus A9™ Stent

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Coronary Artery Disease
• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	BioFreedom™ BA9™ drug-coated stent	Drug-coated stent for coronary arteries

Timeline

• Start date: 2018-03-12
• Primary completion: 2018-04-30
• Completion: 2018-06-30
• First posted: 2017-12-07
• Last updated: 2020-07-01

Locations

1 site across 1 country: Spain