Ischemic Heart DiseasePhase 2/3NCT02131142
BioFreedom US IDE Feasibility Trial
A Phase 2/3 study testing BioFreedom drug coated coronary stent in people with Ischemic Heart Disease and Stable Angina, run by Biosensors Europe SA at 13 sites in United States.
Trial summary
The purpose of this study is to collect additional safety and effectiveness data for on the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Stable Angina, Unstable Angina
- What is being tested?
- BioFreedom drug coated coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2014to Jul 2019
- Phase
- Phase 2/3
- 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
- Individual is ≥ 18 years of age
- Individual must have clinical evidence if ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
- Individual must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
- Individual is competent and willing to provide informed consent to participate in the trial
Who cannot join
- A known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or a sensitivity to contrast media that cannot be adequately pre-medicated;
- History or known allergic reaction or significant sensitivity to drugs similar to BA9;
- A platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, or a WBC < 3,000 cells/mm3;
- A creatinine level > 2.5 mg/dL;
- Evidence of an acute myocardial infarction with 72 hours of the intended stenting (defined as: Q wave or non-Q wave myocardial infarction having a Troponin either I or T pre-procedure elevated above the Institution's upper limit of normal);
- Previous or planned PCI of any vessel within 30 days pre or post procedure;
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- Patient unable to take clopidogrel for 3 months or patient who have comorbidities that would prohibit the cessation of clopidogrel at 3 months;
- Planned adjunctive treatment during the intended stenting (eg balloon valvuloplasty, percutaneous endovascular intervention, etc)
- During the intended or index procedure the target lesion(s) requires treatment with a device other than a plain old balloon prior to stent placement (such as, but not limited to, cutting balloon, directional atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc);
- History of documented prior stroke within 6 months of the intended procedure;
- Active peptic ulcer or upper gastrointestinal bleeding documented within the prior 6 months;
- History of active bleeding diathesis or coagulopathy or will refuse blood transfusion;
- Individual is pregnant, nursing or planning to be pregnant;
- Any previous or planned treatment of the target vessel(s) with anti-restenotic therapies including, but not limited to brachytherapy;
- Concurrent medical condition with a life expectancy of less than 12 months or individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study;
- Individual is currently enrolled in another investigational drug or device trial. If, however, if investigational trial device or drug becomes commercially available, these trials are not considered investigational;
- Previous ACS within 9 months of pre or post procedure
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Emory University Hospital
Atlanta, Georgia, 30322
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
The Carl & Edyth Lindner Center for Research
Cincinnati, Ohio, 45219
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 20735
Jewish Hospital and Saint Mary's Healthcare
Louisville, Kentucky, 40202
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176
Columbia University Medical Center
New York, New York, 10032,
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770
NC Heart and Vascular Research-Rex Hospital
Raleigh, North Carolina, 27607
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608
Our Lady of Lourdes Medical Center
Voorhees Township, New Jersey, 08043
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Berks Cardiology
Wyomissing, Pennsylvania, 19610
About this study
Official title: To Collect Additional Safety and Effectiveness Data for the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in Patients With Native, de Novo Coronary Artery Disease
The purpose of this study is to collect additional safety and effectiveness data for on the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo coronary artery disease.
Read the detailed description
This is a multi-center prospective trial of 100 patients at up to 15 centers. The study population will consist of patients preventing with symptomatic ischemic heart disease due to de novo stenotic lesion(s) in native coronary artery(ies) with reference vessel diameter between 2.25 mm and 4.0 mm.
The primary safety endpoint for this clinical trial is the occurrence of major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, target lesion revascularization and academic research consortium (ARC) definite stent thrombosis within 9 months following the implantation.
The primary effectiveness endpoint for this trial is in-stent late lumen loss at 9 months as compared to historical control
- Being tested
- BioFreedom drug coated coronary stent
- Keywords
- ischemic heart disease, CAD
- Medical subject headings
- Myocardial Ischemia, Angina, Stable, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFreedom drug coated coronary stentDevice
Placement of a BioFreedom drug coated stent in a narrow coronary artery
| Study group | Role | What they receive |
|---|---|---|
| BioFreedom | Experimental | Not described Receives: Device: BioFreedom drug coated coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the BioFreedom stent
The occurrence of major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, target lesion revascularization and academic research consortium (ARC) definite stent thrombosis
Measured: 9 month
Efficacy of the BioFreedom stent
Stent late lumen loss at 9 months as compared to historical control
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131142
- Sponsor's protocol ID
- 14US01
- Status last verified
- Mar 2015
- First submitted
- 5 May 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Collect Additional Safety and Effectiveness Data for the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in Patients With Native, de Novo Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02131142
- Acronym / sponsor ID
- 14US01
- Keywords
- ischemic heart disease, CAD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 6 May 2014 (estimated)
- 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.
The purpose of this study is to collect additional safety and effectiveness data for on the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo coronary artery disease.
Detailed description
This is a multi-center prospective trial of 100 patients at up to 15 centers. The study population will consist of patients preventing with symptomatic ischemic heart disease due to de novo stenotic lesion(s) in native coronary artery(ies) with reference vessel diameter between 2.25 mm and 4.0 mm.
The primary safety endpoint for this clinical trial is the occurrence of major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, target lesion revascularization and academic research consortium (ARC) definite stent thrombosis within 9 months following the implantation.
The primary effectiveness endpoint for this trial is in-stent late lumen loss at 9 months as compared to historical control
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioFreedom | Experimental | Device: BioFreedom drug coated coronary 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)
- Individual is ≥ 18 years of age
- Individual must have clinical evidence if ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
- Individual must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
- Individual is competent and willing to provide informed consent to participate in the trial
Key exclusion criteria (17 listed)
- A known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or a sensitivity to contrast media that cannot be adequately pre-medicated;
- History or known allergic reaction or significant sensitivity to drugs similar to BA9;
- A platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, or a WBC < 3,000 cells/mm3;
- A creatinine level > 2.5 mg/dL;
- Evidence of an acute myocardial infarction with 72 hours of the intended stenting (defined as: Q wave or non-Q wave myocardial infarction having a Troponin either I or T pre-procedure elevated above the Institution's upper limit of normal);
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 drug coated coronary stentPlacement of a BioFreedom drug coated stent in a narrow coronary artery | Device | BioFreedom |
Primary outcome
Safety of the BioFreedom stent
Time frame: 9 month
The occurrence of major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, target lesion revascularization and academic research consortium (ARC) definite stent thrombosis
Efficacy of the BioFreedom stent
Time frame: 9 month
Stent late lumen loss at 9 months as compared to historical control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BioFreedom drug coated coronary stent in people with Ischemic Heart Disease and Stable Angina, run by Biosensors Europe SA at 13 sites in United States.
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 17 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: status not confirmed, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Safety of the BioFreedom stent (time frame: 9 month). 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?
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 Apr 2015.