BioFreedom Pharmacokinetic Study

Study Overview
=================
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-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.

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

Conditions
-----------------
Coronary Artery Disease, Myocardial Infarction

Intervention / Treatment
-----------------
* Device: BioFreedom™ BA9™ drug-coated stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years; Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction; Presence of one or more coronary artery stenoses >50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or more stents; Patient receives one or more BioFreedom stents resulting in a total stent length ranging from 30mm to 45mm; Exclusion Criteria: Individual is pregnant, nursing or planning to be pregnant; Patient presents with STEMI; Known intolerance to aspirin, clopidogrel, heparin, zinc, stainless steel, Biolimus A9TM or contrast material; Inability to provide informed consent; Currently participating in another trial; Treatment with any DES within the previous 6 months; Patient requires a stent <2.25mm; Patient requires a stent >4.0mm; Patient receives a non-study DES stent during the index procedure; Use of a drug coated balloon planned at the index procedure; Systemic use of a -limus drug.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Commercially available BioFreedomTM (stainless steel BA9TM drug-coated stent)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Patients with CAD who receive the BioFreedom™ Biolimus A9™ stent. | Device: BioFreedom™ BA9™ drug-coated stent<br>* Drug-coated stent for coronary arteries<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the maximum concentration (Cmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus | To characterize the maximum concentration (Cmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus | Measured upto 72 hours after stent implantation | 
| To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus | To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus | Measured upto 72 hours after stent implantation |