Status:
COMPLETED
BioFreedom Pharmacokinetic Study
Lead Sponsor:
Biosensors Europe SA
Conditions:
Coronary Artery Disease
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
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 ev...
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 ev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03365492
Start Date
March 12 2018
End Date
June 30 2018
Last Update
July 1 2020
Active Locations (1)
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1
Hospital Clinic de Barcelona
Barcelona, Spain