Leaders Free III: BioFreedom™ Clinical Trial

NCT ID: NCT03118895

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-08
• Study Completion Date: 2022-11-18

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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

Group Type: EXPERIMENTAL

BioFreedom™ BA9™ drug-coated stent

Intervention Type: DEVICE

Drug-coated stent for coronary arteries

Interventions

BioFreedom™ BA9™ drug-coated stent

Drug-coated stent for coronary arteries

Intervention Type: DEVICE

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:

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Cardiovascular Research Center

NETWORK

Sponsor Role: collaborator

Biosensors Europe SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franz Eberli, Prof.

Role: PRINCIPAL_INVESTIGATOR

Chief of Cardiology - Triemli Hospital Zurich - Switzerland

Philippe Garot, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Privé Claude Galien ICPS - France

Locations

at Hôpital Privé Claude Galien ICPS

Quincy-sous-Sénart, Essonne, France

Triemli Stadtspital

Zurich, , Switzerland

Countries

France; Switzerland

References

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.

Reference Type: DERIVED

PMID: 38890129 (View on PubMed)

Other Identifiers

17EU01

Identifier Type: -

Identifier Source: org_study_id