Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03365492
Status:
COMPLETED
Last Update Posted:
2020-07-01
First Post:
2017-11-23
Brief Title:
BioFreedom Pharmacokinetic Study
Sponsor:
Biosensors Europe SA
Organization:
Biosensors Europe SA
Study Overview
Official Title:
BioFreedom PK Study in Patients With CAD Who Receive the BioFreedom Biolimus A9 Stent
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-MSMS 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
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-MSMS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None