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BioFreedom Pharmacokinetic Study

Primary Purpose

Coronary Artery Disease, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
BioFreedom™ BA9™ drug-coated stent
Sponsored by
Biosensors Europe SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clinic de Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Patients with CAD who receive the BioFreedom™ Biolimus A9™ stent.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
November 23, 2017
Last Updated
June 29, 2020
Sponsor
Biosensors Europe SA
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1. Study Identification

Unique Protocol Identification Number
NCT03365492
Brief Title
BioFreedom Pharmacokinetic Study
Official Title
BioFreedom PK Study in Patients With CAD Who Receive the BioFreedom™ Biolimus A9™ Stent
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosensors Europe SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Commercially available BioFreedomTM (stainless steel BA9TM drug-coated stent)
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Patients with CAD who receive the BioFreedom™ Biolimus A9™ stent.
Intervention Type
Device
Intervention Name(s)
BioFreedom™ BA9™ drug-coated stent
Intervention Description
Drug-coated stent for coronary arteries
Primary Outcome Measure Information:
Title
To characterize the maximum concentration (Cmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus
Description
To characterize the maximum concentration (Cmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus
Time Frame
Measured upto 72 hours after stent implantation
Title
To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus
Description
To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus
Time Frame
Measured upto 72 hours after stent implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

BioFreedom Pharmacokinetic Study

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