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Clinical Trial Details

Title
16US01: A Prospective Study of the BioFreedom™ Biolimus A9TM Drug Coated Stent in Patients at High Risk for Bleeding (Leaders Free II)
Study Description

The purpose of the study is to determine the best way of treating the coronary artery narrowing of patients at higher risk of bleeding. The study will evaluate if treatment with the drug coated stent is similar to conventional treatment with a bare metal stent, both followed by one month of dual antiplatelet treatment.

If you decide to take part, you will undergo coronary angioplasty as normal, during which the BioFreedom™ Coronary Stent will be used. Before and after the procedure you will take two blood-thinning medications to prevent blood from clotting within the stent. These drugs, Aspirin and P2Y12 inhibitor, are used routinely following stent placement in this hospital. You may also get other medications. Your progress will be monitored throughout your hospital stay and at 1, 2 and 6 months as well as at 1, 2 and 3 years. If you have no problems, your 2 month as well as 2 year and 3 year follow-up may be done over the telephone. The Follow-Up at 1 month, 6 months and 1 year should be done at the hospital. Blood samples (about 2 tablespoons) will be collected for the study before your procedure and before you go home. This will be done whether you participate in this study or not and are routine for your procedure. If you are a female of child-bearing potential, you should have a pregnancy test to rule out pregnancy up to 7 days before stent placement. You will not be asked to undergo any testing that is not standard of care at your treating hospital for patients with your condition.

Investigators

Principal Investigator
Dominick J. Angiolillo, M.D., Ph.D., FACC
Medicine

Sub Investigator
Theodore A. Bass, M.D.
Medicine

Sub Investigator
Daniel Soffer, M.D.
Medicine

Sub Investigator
Siva Suryadevara, M.B.B.S. (M.D.)
Medicine

Sub Investigator
Martin "M" Zenni, M.D.
Medicine

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