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Leaders Free III: BioFreedom™ Clinical Trial

Primary Purpose

Cardiac Death, Myocardial Infarction, Stent Thrombosis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

BioFreedom™ BA9™ drug-coated stent

About this trial

This is an interventional treatment trial for Cardiac Death

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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:

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
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

Exclusion Criteria:

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
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

Sites / Locations

at Hôpital Privé Claude Galien ICPS
Triemli Stadtspital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Patients with coronary artery disease at high risk of bleeding receiving the BioFreedom™ BA9™ drug-coated stent

Outcomes

Primary Outcome Measures

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

Incidence

clinically driven target lesion revascularization (efficacy)

incidence

Secondary Outcome Measures

All-cause mortality

incidence

Clinically Driven Target Lesion Revascularization

Incidence

Clinically Driven Target Vessel Revascularization

Incidence

Full Information

NCT ID

NCT03118895

First Posted

April 9, 2017

Last Updated

October 28, 2022

Sponsor

Biosensors Europe SA

Collaborators

European Cardiovascular Research Center

1. Study Identification

Unique Protocol Identification Number

NCT03118895

Brief Title

Leaders Free III: BioFreedom™ Clinical Trial

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

November 8, 2017 (Actual)

Primary Completion Date

February 5, 2020 (Actual)

Study Completion Date

October 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biosensors Europe SA

Collaborators

European Cardiovascular Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Death, Myocardial Infarction, Stent Thrombosis, Bleeding, Mortality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

370 high bleeding risk items

Allocation

N/A

Enrollment

404 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

Patients with coronary artery disease at high risk of bleeding receiving the BioFreedom™ BA9™ drug-coated stent

Intervention Type

Device

Intervention Name(s)

BioFreedom™ BA9™ drug-coated stent

Intervention Description

Drug-coated stent for coronary arteries

Primary Outcome Measure Information:

Title

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

Description

Incidence

Time Frame

at 1 year

Title

clinically driven target lesion revascularization (efficacy)

Description

incidence

Time Frame

at 1 year

Secondary Outcome Measure Information:

Title

All-cause mortality

Description

incidence

Time Frame

At 1 and 4 months, and 1 and 2 years

Title

Clinically Driven Target Lesion Revascularization

Description

Incidence

Time Frame

At 1 and 4 months, and 2 years

Title

Clinically Driven Target Vessel Revascularization

Description

Incidence

Time Frame

At 1 and 4 months, and 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franz Eberli, Prof.

Organizational Affiliation

Chief of Cardiology - Triemli Hospital Zurich - Switzerland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Philippe Garot, MD

Organizational Affiliation

Hôpital Privé Claude Galien ICPS - France

Official's Role

Principal Investigator

Facility Information:

Facility Name

at Hôpital Privé Claude Galien ICPS

City

Quincy sous Sénart

State/Province

Essonne

ZIP/Postal Code

91480

Country

France

Facility Name

Triemli Stadtspital

City

Zürich

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

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Leaders Free III: BioFreedom™ Clinical Trial

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