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BioFreedom Pharmacokinetic Study

Sponsor
Biosensors Europe SA (Industry)
Overall Status
Completed
CT.gov ID
NCT03365492
Collaborator
(none)
17
Enrollment
1
Location
1
Arm
3.6
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BioFreedom™ BA9™ drug-coated stent
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Commercially available BioFreedomTM (stainless steel BA9TM drug-coated stent)Commercially available BioFreedomTM (stainless steel BA9TM drug-coated stent)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
BioFreedom PK Study in Patients With CAD Who Receive the BioFreedom™ Biolimus A9™ Stent
Actual Study Start Date :
Mar 12, 2018
Actual Primary Completion Date :
Apr 30, 2018
Actual Study Completion Date :
Jun 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Arm

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

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

Outcome Measures

Primary Outcome Measures

  1. 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 maximum concentration (Cmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus

  2. 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]

    To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clinic de Barcelona Barcelona Spain

Sponsors and Collaborators

  • Biosensors Europe SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biosensors Europe SA
ClinicalTrials.gov Identifier:
NCT03365492
Other Study ID Numbers:
  • 17EU03
First Posted:
Dec 7, 2017
Last Update Posted:
Jul 1, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Infarction
Infarction

Study Results

No Results Posted as of Jul 1, 2020