LEADERS FREE II: BioFreedom™ Pivotal Study

• Status: Active, not recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biosensors Europe SA
• Treatments: Platelet Aggregation Inhibitors

Criteria

Inclusion Criteria:

Any indication for percutaneous coronary intervention with stent placement (PCI-S) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute coronary syndrome (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 the index procedure)

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, with a perceived increased risk for bleeding

8. Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for >30 days after PCI

9. Planned surgery that would require interruption of DAPT (within next 6 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 planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy

5. Active bleeding at the time of inclusion

6. Reference vessel diameter <2.25 - >4.0mm

7. Cardiogenic shock

8. Compliance with long-term single anti-platelet therapy unlikely

9. A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated

10. PCI during the previous 12 months for a lesion other than the target lesion of the index procedure

11. Participation in another clinical trial (12 months after index procedure)

12. Patients with a life expectancy of < 12 months

13. Patients under judicial protection, tutorship or curatorship (for France only)