Clinical trial NCT03365492: BioFreedom Pharmacokinetic Study
Official title: BioFreedom PK Study in Patients With CAD Who Receive the BioFreedom™ Biolimus A9™ Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2017-12-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Commercially available BioFreedomTM (stainless steel BA9TM drug-coated stent)
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction;
3. 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;
4. Patient receives one or more BioFreedom stents resulting in a total stent length ranging from 30mm to 45mm;

Exclusion Criteria:

1. Individual is pregnant, nursing or planning to be pregnant;
2. Patient presents with STEMI;
3. Known intolerance to aspirin, clopidogrel, heparin, zinc, stainless steel, Biolimus A9TM or contrast material;
4. Inability to provide informed consent;
5. Currently participating in another trial;
6. Treatment with any DES within the previous 6 months;
7. Patient requires a stent \<2.25mm;
8. Patient requires a stent \>4.0mm;
9. Patient receives a non-study DES stent during the index procedure;
10. Use of a drug coated balloon planned at the index procedure;
11. Systemic use of a -limus drug.

Primary outcomes:
measure: To characterize the maximum concentration (Cmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus
timeFrame: Measured upto 72 hours after stent implantation
measure: To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus
timeFrame: Measured upto 72 hours after stent implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References: