Leaders Free III: BioFreedom™ Clinical Trial

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: Completed
• Conditions: Myocardial Infarction; Mortality; Bleeding; Cardiac Death; Stent Thrombosis
• Intervention / Treatment: Device: BioFreedom™ BA9™ drug-coated stent

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: Interventional
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)	Incidence	at 1 year
clinically driven target lesion revascularization (efficacy)	incidence	at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	incidence	At 1 and 4 months, and 1 and 2 years
Clinically Driven Target Lesion Revascularization	Incidence	At 1 and 4 months, and 2 years
Clinically Driven Target Vessel Revascularization	Incidence	At 1 and 4 months, and 2 years

Collaborators and Investigators

• Sponsor: Biosensors Europe SA
• Collaborators: European Cardiovascular Research Center
• Investigators: 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

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): September 5, 2019
• Study Completion (Actual): November 18, 2022

Study Registration Dates

• First Submitted: April 9, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Myocardial Infarction; Infarction; Death; Hemorrhage; Thrombosis
• Other Study ID 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