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Cardiac DeathNCT03118895

Leaders Free III: BioFreedom™ Clinical Trial

A study testing BioFreedom™ BA9™ drug-coated stent in people with Cardiac Death and Myocardial Infarction, run by Biosensors Europe SA at 2 sites in 2 countries.

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

A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding Read more about this study

Who is it for?
Ages 75 years and older
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
404 participants
Where
2 sitesin 2 countries
Study dates
8 Nov 2017to 18 Nov 2022
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients at high bleeding risk (HBR) with an indication for percutaneous coronary intervention who can tolerate no more than one month of DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
  • Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or MORE of the following:
  • Adjunctive oral anticoagulation treatment planned to continue after PCI
  • Age ≥ 75 years old
  • Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to inclusion into the trial)
  • Any prior intracerebral bleed
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  • Any stroke in the last 12 months
  • Hospital admission for bleeding during the prior 12 months
  • Non skin cancer diagnosed or treated ≤ 3 years
  • Planned daily NSAID (other than aspirin) or steroids for ≥ 30 days after PCI
  • Planned surgery that would require interruption of DAPT (within next 12 months)
  • Renal failure defined as: Creatinine clearance <40 ml/min
  • Thrombocytopenia (PLT <100,000/mm3)
  • Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
  • Expected non-compliance to prolonged DAPT for other medical reasons

Who cannot join

  • Pregnant and breastfeeding women
  • Patients expected not to comply with 1 month DAPT
  • Patients requiring a planned staged PCI procedure more than one week after the index procedure
  • Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only).
  • Active bleeding at the time of inclusion
  • If patient requires a stent <2.5mm
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  • If patient requires a stent >3.5mm
  • Cardiogenic shock
  • Compliance with long-term single anti-platelet therapy unlikely
  • Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any another P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9TM or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • PCI during the previous 12 months for a lesion other than the target lesion
  • Participation in another clinical trial (12 months after index procedure)
  • Patients with a life expectancy of < 1 year

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

France1 site

  • at Hôpital Privé Claude Galien ICPS

    Quincy-sous-Sénart, Essonne, 91480

Other trials in France

Switzerland1 site

  • Triemli Stadtspital

    Zurich

Other trials in Switzerland

About this study

Official title: A Study Evaluating the Safety and Efficacy of the BioFreedom™ Biolimus A9™ Coated Cobalt Chromium Coronary Stent System in Patients at High Risk of Bleeding

A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding

Read the detailed description

Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 years.

Being tested
BioFreedom™ BA9™ drug-coated stent
Medical subject headings
Death, Myocardial Infarction, Hemorrhage

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 NCT03118895
Study groupRoleWhat they receive
Treatment ArmExperimentalPatients with coronary artery disease at high risk of bleeding receiving the BioFreedom™ BA9™ drug-coated 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.

  1. MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)

    Incidence

    Measured: at 1 year

  2. clinically driven target lesion revascularization (efficacy)

    incidence

    Measured: at 1 year

Secondary outcomes (3)

  1. All-cause mortality

    incidence

    Measured: At 1 and 4 months, and 1 and 2 years

  2. Clinically Driven Target Lesion Revascularization

    Incidence

    Measured: At 1 and 4 months, and 2 years

  3. Clinically Driven Target Vessel Revascularization

    Incidence

    Measured: At 1 and 4 months, and 2 years

Timeline

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

  1. First posted18 Apr 2017
  2. Study start8 Nov 2017
  3. Primary completion5 Sep 2019
  4. Study completion18 Nov 2022

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03118895
Sponsor's protocol ID
17EU01
Status last verified
Feb 2024
First submitted
9 Apr 2017
Last updated
29 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eberli FR, Oldroyd KG, Urban P, Krucoff MW, Morice MC, Tanguay JF, Leon MB, Brunel P, Maillard L, Lipiecki J, Cook S, Berland J, Hovasse T, Carrie D, Schutte D, Sadozai Slama S, Garot P. Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years. Open Heart. 2024 Jun 18;11(1):e002679. doi: 10.1136/openhrt-2024-002679.

    PubMed 38890129

Questions about this trial

What is this clinical trial studying?

A study testing BioFreedom™ BA9™ drug-coated stent in people with Cardiac Death and Myocardial Infarction, run by Biosensors Europe SA at 2 sites in 2 countries.

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 15 inclusion and 13 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 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, Switzerland. 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?

MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety) (time frame: at 1 year). 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 NCT03118895, 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 29 Feb 2024.

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