Clinical trial NCT03118895: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Death
Myocardial Infarction
Stent Thrombosis
Bleeding
Mortality
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2017-04-18
Enrollment: 404
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)
timeFrame: at 1 year
measure: clinically driven target lesion revascularization (efficacy)
timeFrame: at 1 year
Secondary outcomes:
measure: All-cause mortality
timeFrame: At 1 and 4 months, and 1 and 2 years
measure: Clinically Driven Target Lesion Revascularization
timeFrame: At 1 and 4 months, and 2 years
measure: Clinically Driven Target Vessel Revascularization
timeFrame: At 1 and 4 months, and 2 years
Other outcomes:
Locations:
city: Quincy sous Sénart
country: France
facility: at Hôpital Privé Claude Galien ICPS
state: Essonne
city: Zürich
country: Switzerland
facility: Triemli Stadtspital
Study officials:
affiliation: Chief of Cardiology - Triemli Hospital Zurich - Switzerland
name: Franz Eberli, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Privé Claude Galien ICPS - France
name: Philippe Garot, MD
role: PRINCIPAL_INVESTIGATOR
References: