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Treatment Of Stenotic Lesions In Native Coronary Arteries.Phase 2/3NCT01172119

BioFreedom FIM Clinical Trial.

A Phase 2/3 study testing Biofreedom Drug Eluting Stent and Tuxus Liberte Drug Eluting Stent in people with Treatment Of Stenotic Lesions In Native Coronary Arteries., run by Biosensors Europe SA at 4 sites in Germany.

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

Prospective, multi center, randomized, single blinded study designed to demonstrate the safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery System at multiple time points compared to the Taxus Liberte DES in the treatment of single de novo native coronary artery lesions ranging… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biofreedom Drug Eluting Stent and Tuxus Liberte Drug Eluting Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
4 sitesGermany
Study dates
Aug 2008to Jul 2014
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

  • The subject is >18 years of age.
  • The subject is an acceptable candidate for PTCA, stenting, and emergent CABG.
  • Patients with multiple lesions as long as the last lesion to be treated fits the Inclusion criteria of the target lesion.
  • The subject must have clinical evidence of ischemic heart disease or a positive functional study.
  • The study stent target vessel must be a native coronary artery with a stenosis of >50% and <100%.
  • The study stent target vessel reference diameter must be >2.5 mm and ≤ 3.0 mm.(Measurements may be made by careful visual estimate or on-line quantitative coronary angiography.)
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  • The study stent target lesion is a de novo lesion that has not been previously stented.
  • The study stent target lesion must be ≤ 14 mm in length thus allowing for adequate lesion coverage with a single stent.
  • The subject is male or, if female, is either not of childbearing potential or has had a negative pregnancy test within seven (7) days prior to the procedure.
  • The subject or the subject's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee (IEC) of the clinical site.
  • The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Who cannot join

  • Multiple lesions to be treated in the same target vessel.
  • Patients who require more than one BioFreedom stent except that an additional BioFreedom stent may be implanted in the target lesion for geographic miss or bailout
  • A documented left ventricular ejection fraction < 30% assessed within 6 months prior to procedure by echocardiography, during a previous angiography or as measured during pre-procedure angiography.
  • A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine and, clopidogrel, stainless steel, Biolimus A9, Paclitaxel or a sensitivity to contrast media, which cannot be adequately pre-medicated.
  • A platelet count <100,000 cells/mm³ or >700,000 cells/mm³, or a WBC <3,000 cells/mm³.
  • Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave infarction having CK enzymes > 2 times the upper laboratory normal with the presence of a CK-MB elevated above the institutions upper limit of normal).
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  • A previous coronary interventional procedure was performed either a.) within 24 hours prior to the procedure or b.) within 12 months prior to the procedure for any lesion in the target vessel.
  • The subject requires planned interventional treatment of any lesion in either the target vessel within 12 months or in any non-target vessel within 30 days post-procedure.
  • The target and non-target lesion require treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
  • The target vessel has angiographic evidence of thrombus or is excessively (2 bends > 90º to reach the target lesion) tortuous.
  • The target lesion has any of the following characteristics:
  • Lesion location is aorto-ostial, left main coronary artery, or within 5 mm of the origin of the LAD, LCX, or RCA.
  • Is at a >45º bend in the vessel.
  • Is moderately to severely calcified (visible by fluoro).
  • Stenting of the target or non-target lesion would "jail" or cover a side branch >2.0 mm in diameter or occur at the ostium of the sidebranch.
  • History of a stroke or transient ischemic attack (TIA) within the prior 6 months or permanent neurologic deficit.
  • History of upper GI bleeding within the prior 6 months.
  • The subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Concurrent medical condition with a life expectancy of less than 18 months.
  • Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. [Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.]
  • Any contraindications as mentioned in the TaxusTM LiberteTM Instructions for Use (IFU).

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Medical Care Center, Hamburg University Cardiovascular Center

    Hamburg, D-22527

  • Herzzentrum Leipzig GmbH

    Leipzig, D-04289

  • HELIOS - Klinikum Siegburg

    Siegburg, D-53721

  • Krankenhaus der Barmherzigen Brüder

    Trier, D-54292 Trier

Other trials in Germany

About this study

Official title: A Prospective, Single Blinded, Randomized Study to Evaluate the Safety and Effictiveness of a Low and Standard Dose Biolimus A9TM Drug-Eluteing Coronary Stent Delivery System Compared With a TaxusTM LiberteTM Control Arm for Treatment of Stenotic Lesions in Native Coronary Arteries.

Prospective, multi center, randomized, single blinded study designed to demonstrate the safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery System at multiple time points compared to the Taxus Liberte DES in the treatment of single de novo native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.0 mm and ≤ 14 mm in length.

Being tested
Biofreedom Drug Eluting Stent, Tuxus Liberte Drug Eluting Stent
Keywords
Coronary Disease, Coronary Stenosis, Angioplasty, Coronary restenosis, Drug Eluting Stent
Medical subject headings
Coronary Disease, Coronary Stenosis, Coronary Restenosis

What participants receive

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

  • Biofreedom Drug Eluting StentDevice

    Biofreedom DES with a standard dose of Biolimus A9TM

  • Biofreedom Drug Eluting StentDevice

    Biofreedom DES with a low dose of Biolimus A9TM

  • Tuxus Liberte Drug Eluting StentDevice

    Standard paclitaxel dose Taxus Liberte DES

Study groups in NCT01172119
Study groupRoleWhat they receive
BioFreedom Standard DoseExperimentalNot described
Receives: Device: Biofreedom Drug Eluting Stent
BioFreedom Low DoseExperimentalNot described
Receives: Device: Biofreedom Drug Eluting Stent
Taxus Liberte drug eluting stentsActive comparatorNot described
Receives: Device: Tuxus Liberte Drug Eluting Stent

What is being measured

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

  1. In-Stent Late Lumen Loss at 12 months post-procedure.

    Measured: 12 Months

Secondary outcomes (6)

  1. In-Stent Late Lumen Loss (LL) at 4 months post-procedure for patients receiving IVUS/Angio at 4 months

    Measured: 4 months

  2. 2. Major adverse cardiac events (MACE) at 30 days, defined as death, myocardial infarction or ischemic target vessel revascularization (PCI or CABG).

    Measured: 30 days

  3. 3. Major Adverse Cardiac Event (MACE) at hospital discharge, 30 days, 4 months, 12 months, and 2, 3, 4 and 5 years post-procedure.

    Measured: 5 years

  4. Vascular complications through hospital discharge.

    Measured: 5 years

  5. 5. Rates of stent thrombosis, per ARC definition of definite and probable and categorized as early, late or very late, at 30 days, 4 and 12 months, 2, 3, 4 and 5 years post-procedure.

    Measured: 5 years

  6. 6. Biolimus A9 drug systemic drug levels post-procedure, 4 hours post-procedure, at hospital discharge, and at 30 days and 4 months clinical follow-up.

    Measured: 4 months

Timeline

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

  1. First posted29 Jul 2010 (estimated)
  2. Study startAug 2008
  3. Primary completionJun 2010
  4. Study completionJul 2014

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01172119
Sponsor's protocol ID
08EU01
Status last verified
Sep 2014
First submitted
28 Jul 2010
Last updated
9 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Costa RA, Abizaid A, Mehran R, Schofer J, Schuler GC, Hauptmann KE, Magalhaes MA, Parise H, Grube E; BioFreedom FIM Clinical Trial Investigators. Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions: 4- and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial. JACC Cardiovasc Interv. 2016 Jan 11;9(1):51-64. doi: 10.1016/j.jcin.2015.09.008.

    PubMed 26762911

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Biofreedom Drug Eluting Stent and Tuxus Liberte Drug Eluting Stent in people with Treatment Of Stenotic Lesions In Native Coronary Arteries., run by Biosensors Europe SA at 4 sites in Germany.

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 11 inclusion and 21 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 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. 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?

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?

In-Stent Late Lumen Loss at 12 months post-procedure. (time frame: 12 Months). 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 NCT01172119, which also lists 1 linked publication.

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 9 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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