Leaders Free III: BioFreedom™ Clinical Trial

• ClinicalTrials.gov Identifier: NCT03118895
• Recruitment Status: Completed
• First Posted: April 18, 2017
• Last Update Posted: October 31, 2022
• Sponsor: Biosensors Europe SA
• Collaborator: European Cardiovascular Research Center
• Information provided by (Responsible Party): Biosensors Europe SA

Tracking Information

• First Submitted Date: April 9, 2017
• First Posted Date: April 18, 2017
• Last Update Posted Date: October 31, 2022
• Actual Study Start Date: November 8, 2017
• Actual Primary Completion Date: February 5, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2017)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 5, 2017)

• All-cause mortality [ Time Frame: At 1 and 4 months, and 1 and 2 years ]
  incidence
• Clinically Driven Target Lesion Revascularization [ Time Frame: At 1 and 4 months, and 2 years ]
  Incidence
• Clinically Driven Target Vessel Revascularization [ Time Frame: At 1 and 4 months, and 2 years ]
  Incidence

Original Secondary Outcome Measures (submitted: April 13, 2017)

• All-cause mortality [ Time Frame: At 1 and 4 months, and 1 and 2 years ]
  incidence
• Clinically Driven Target Lesion Revascularization [ Time Frame: At 1 and 4 months, and 2 years ]
  incidence
• Clinically Driven Target Vessel Revascularization [ Time Frame: At 1 and 4 months, and 2 years ]
  incidence

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:

370 high bleeding risk items

Primary Purpose: Treatment

Condition

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

Intervention

Device: BioFreedom™ BA9™ drug-coated stent

Drug-coated stent for coronary arteries

Study Arms

Experimental: Treatment Arm

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

Intervention: Device: BioFreedom™ BA9™ drug-coated stent

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 23, 2019): 404
• Original Estimated Enrollment (submitted: April 13, 2017): 370
• Actual Study Completion Date: October 7, 2022
• Actual Primary Completion Date: February 5, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 75 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Switzerland
• Removed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03118895
• Other Study ID Numbers: 17EU01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Biosensors Europe SA
• Original Responsible Party: Same as current
• Current Study Sponsor: Biosensors Europe SA
• Original Study Sponsor: Same as current
• 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

• PRS Account: Biosensors Europe SA
• Verification Date: October 2022