Coronary Artery DiseaseNCT03365492

BioFreedom Pharmacokinetic Study

A study testing BioFreedom™ BA9™ drug-coated stent in people with Coronary Artery Disease and Myocardial Infarction, run by Biosensors Europe SA at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Myocardial Infarction
What is being tested?: BioFreedom™ BA9™ drug-coated stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteSpain
Study dates: 12 Mar 2018to 30 Jun 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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;

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Clinic de Barcelona
Barcelona

Other trials in Spain

About this study

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

Read the detailed description

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.

Conditions: Coronary Artery Disease, Myocardial Infarction
Being tested: BioFreedom™ BA9™ drug-coated stent
Medical subject headings: Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BioFreedom™ BA9™ drug-coated stentDevice
Drug-coated stent for coronary arteries

Study groups in NCT03365492
Study group	Role	What they receive
Treatment Arm	Experimental	Patients with CAD who receive the BioFreedom™ Biolimus A9™ stent. Receives: Device: BioFreedom™ BA9™ drug-coated stent

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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
To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus
Measured: Measured upto 72 hours after stent implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 201830 Jun 2018

First posted7 Dec 2017
Study start12 Mar 2018
Primary completion30 Apr 2018
Study completion30 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Commercially available BioFreedomTM (stainless steel BA9TM drug-coated stent)
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03365492
Sponsor's protocol ID: 17EU03
Status last verified: Jun 2020
First submitted: 23 Nov 2017
Last updated: 1 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BioFreedom PK Study in Patients With CAD Who Receive the BioFreedom™ Biolimus A9™ Stent
ClinicalTrials.gov ID: NCT03365492
Acronym / sponsor ID: 17EU03
Conditions: Coronary Artery Disease, Myocardial Infarction
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Biosensors Europe SAIndustry (pharma, biotech, devices)
Study start: 12 Mar 2018 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 7 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Commercially available BioFreedomTM (stainless steel BA9TM drug-coated stent)

Arm	Type	Receives
Treatment Arm	Experimental	Device: BioFreedom™ BA9™ drug-coated stentPatients with CAD who receive the BioFreedom™ Biolimus A9™ stent.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BioFreedom™ BA9™ drug-coated stentDrug-coated stent for coronary arteries	Device	Treatment Arm

Primary outcome

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
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
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.

Related trials for Coronary Artery Disease

Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingObservational study
Coronary Myocardial Bridge and Coronary Plaques on MDCT
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Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BioFreedom™ BA9™ drug-coated stent in people with Coronary Artery Disease and Myocardial Infarction, run by Biosensors Europe SA at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03365492.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.