Leaders Free III: BioFreedom™ Clinical Trial

NCT03118895 | Completed DMC

• 1 other identifier: 17EU01
• Study Type: interventional
• Target: 404
• Locations: 2 countries
• Sites: 2

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• All-cause mortality

  At 1 and 4 months, and 1 and 2 years

• Clinically Driven Target Lesion Revascularization

  At 1 and 4 months, and 2 years

• Clinically Driven Target Vessel Revascularization

  At 1 and 4 months, and 2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Device: BioFreedom™ BA9™ drug-coated stent

Interventions

BioFreedom™ BA9™ drug-coated stent DEVICE

Drug-coated stent for coronary arteries

Treatment Arm

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Biosensors Europe SA: lead
• European Cardiovascular Research Center: collaborator

Study Sites (2)

at Hôpital Privé Claude Galien ICPS

Quincy-sous-Sénart, Essonne, 91480, France

Location

Triemli Stadtspital

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 38890129 DERIVED

MeSH Terms

Conditions

Death; Myocardial Infarction; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Officials

• Franz Eberli, Prof.

  Chief of Cardiology - Triemli Hospital Zurich - Switzerland

  PRINCIPAL INVESTIGATOR

• Philippe Garot, MD

  Hôpital Privé Claude Galien ICPS - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 370 high bleeding risk items
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2017
• First Posted: April 18, 2017
• Study Start: November 8, 2017
• Primary Completion: September 5, 2019
• Study Completion: November 18, 2022
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); FR (1)