Leaders Free III: BioFreedom™ Clinical Trial

February 28, 2024 updated by: Biosensors Europe SA

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
404

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Essonne
      • Quincy sous Sénart, Essonne, France, 91480
        • at Hôpital Privé Claude Galien ICPS
  • Switzerland
      • Zürich, Switzerland
        • Triemli Stadtspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

71 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

  1. Adjunctive oral anticoagulation treatment planned to continue after PCI
  2. Age ≥ 75 years old
  3. Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to inclusion into the trial)
  4. Any prior intracerebral bleed
  5. Any stroke in the last 12 months
  6. Hospital admission for bleeding during the prior 12 months
  7. Non skin cancer diagnosed or treated ≤ 3 years
  8. Planned daily NSAID (other than aspirin) or steroids for ≥ 30 days after PCI
  9. Planned surgery that would require interruption of DAPT (within next 12 months)
  10. Renal failure defined as: Creatinine clearance <40 ml/min
  11. Thrombocytopenia (PLT <100,000/mm3)
  12. Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
  13. Expected non-compliance to prolonged DAPT for other medical reasons

Exclusion Criteria:

  1. Pregnant and breastfeeding women
  2. Patients expected not to comply with 1 month DAPT
  3. Patients requiring a planned staged PCI procedure more than one week after the index procedure
  4. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only).
  5. Active bleeding at the time of inclusion
  6. If patient requires a stent <2.5mm
  7. If patient requires a stent >3.5mm
  8. Cardiogenic shock
  9. Compliance with long-term single anti-platelet therapy unlikely
  10. 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
  11. PCI during the previous 12 months for a lesion other than the target lesion
  12. Participation in another clinical trial (12 months after index procedure)
  13. Patients with a life expectancy of < 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm
Patients with coronary artery disease at high risk of bleeding receiving the BioFreedom™ BA9™ drug-coated stent
Device: BioFreedom™ BA9™ drug-coated stent
Drug-coated stent for coronary arteries

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)
Time Frame: at 1 year
Incidence
at 1 year
clinically driven target lesion revascularization (efficacy)
Time Frame: at 1 year
incidence
at 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: At 1 and 4 months, and 1 and 2 years
incidence
At 1 and 4 months, and 1 and 2 years
Clinically Driven Target Lesion Revascularization
Time Frame: At 1 and 4 months, and 2 years
Incidence
At 1 and 4 months, and 2 years
Clinically Driven Target Vessel Revascularization
Time Frame: At 1 and 4 months, and 2 years
Incidence
At 1 and 4 months, and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosensors Europe SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Cardiovascular Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Franz Eberli, Prof., Chief of Cardiology - Triemli Hospital Zurich - Switzerland
  • Principal Investigator: Philippe Garot, MD, Hôpital Privé Claude Galien ICPS - France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17EU01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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