LEADERS FREE II: BioFreedom™ Pivotal Study



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:1/17/2019
Start Date:February 14, 2017
End Date:October 2020

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A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding

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 in high bleeding risk patients.

In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of
Dual Anti Platelet Therapy

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)
We found this trial at
40
sites
La Jolla, California 92037
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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Anderson, South Carolina 29621
Phone: 864-512-8734
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Anderson, SC
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Bay City, Michigan 48708
Phone: 989-894-3290
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Boise, ID
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Buffalo, New York 14215
Phone: 716-888-4859
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Buffalo, NY
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Charlotte, North Carolina 28204
Phone: 704-264-1386
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Chattanooga, Tennessee 37404
Phone: 423-495-2173
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Chicago, Illinois 60612
Phone: 312-569-7464
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Chicago, IL
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Columbia, Missouri 65201
Phone: 573-256-3046
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Columbia, MO
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11220 83 Avenue Northwest
Edmonton, Alberta T6G 2B7
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Edmonton,
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Gainesville, Georgia 30501
Phone: 678-989-5001
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Greensboro, North Carolina 27401
Phone: 336-832-3796
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Phone: 717-531-6855
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hot Springs, Arkansas 71901
Phone: 501-622-7691
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Huntsville, Alabama 35801
Phone: 256-519-8203
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Indianapolis, Indiana 46290
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Jacksonville, Florida 32209
Phone: 904-244-2962
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Phone: 816-932-7528
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Knoxville, Tennessee 37934
Phone: 865-218-7540
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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201 Abraham Flexner Way # 904
Louisville, Kentucky 40202
Phone: 502-540-3409
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Midland, Michigan 48670
Phone: 989-839-3018
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New York, NY
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Philadelphia, Pennsylvania
Phone: 215-662-9019
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Raleigh, North Carolina 27610
Phone: 919-784-7695
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Rapid City, South Dakota 57701
Phone: 605-755-3763
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2605 Keiser Boulevard
Reading, Pennsylvania 19610
Phone: 610-685-4843
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Roanoke, Virginia
Phone: 540-632-9852
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Royal Oak, Michigan 48073
Phone: 248-898-9161
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Santa Barbara, California 93105
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Sarasota, Florida 34233
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Tallahassee, Florida 32308
Phone: 850-431-5024
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Waco, Texas 76712
Phone: 254-751-4143
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Washington, District of Columbia
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Wormleysburg, Pennsylvania 17043
Phone: 717-920-4400
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800 Forest Ave.
Zanesville, Ohio 43701
(740) 454-5000
Phone: 740-455-7640
Genesis Healthcare System Genesis HealthCare System is an integrated health care delivery system based in...
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