BioFreedom Pharmacokinetic Study

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365492
• Other study ID #: 17EU03
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2020
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Intervention

Device:
• BioFreedom™ BA9™ drug-coated stent
Drug-coated stent for coronary arteries

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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