LEADERS FREE II: BioFreedom™ Pivotal Study

Running, not enrolling · Not applicable

Conditions studied: Acute Coronary Syndrome, High Bleeding Risk

In brief

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.

Key facts

Study ID

NCT02843633

Run by

Biosensors Europe SA

People needed

1203

Starts

2017-02-14

Expected to finish

2021-03-01

Last updated by the study team

2021-02-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Adjunctive oral anticoagulation treatment planned to continue after PCI
• Age ≥ 75 years old
• Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure)
• 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, with a perceived increased risk for bleeding
• Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for >30 days after PCI
• Planned surgery that would require interruption of DAPT (within next 6 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 planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy
• Active bleeding at the time of inclusion
• Reference vessel diameter <2.25 - >4.0mm
• Cardiogenic shock
• Compliance with long-term single anti-platelet therapy unlikely
• 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
• PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
• Participation in another clinical trial (12 months after index procedure)
• Patients with a life expectancy of < 12 months
• Patients under judicial protection, tutorship or curatorship (for France only)

Where it is running

• Tri-Lakes Research — Hot Springs, Arkansas, United States
• Scripps Health — La Jolla, California, United States
• University of California San Diego — La Jolla, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida Jacksonville — Jacksonville, Florida, United States
• Velella Research — Sarasota, Florida, United States
• Tallahassee Research Institute, Inc. — Tallahassee, Florida, United States
• North Georgia Heart Foundation — Gainesville, Georgia, United States
• St. Luke's Idaho Cardiology Associates — Boise, Idaho, United States
• Jesse Brown VA Medical Center — Chicago, Illinois, United States
• St. Vincent Heart Center — Indianapolis, Indiana, United States
• Jewish and St. Mary's Hospital — Louisville, Kentucky, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• McLaren Bay Region — Bay City, Michigan, United States
• MidMichigan Medical Center Midland — Midland, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Missouri Cardiovascular Specialists, LLP — Columbia, Missouri, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• University of Buffalo — Buffalo, New York, United States
• Weill Cornell Medical College-New York Presbyterian — New York, New York, United States
• Columbia University Medical Center/New York Presbyterian Hospital — New York, New York, United States
• Novant Health Heart and Vascular Institute — Charlotte, North Carolina, United States
• LeBauer Cardiovascular Research Foundation — Greensboro, North Carolina, United States
• Heart Center Research, LLC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.