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Primary Diagnosis

Coronary Artery Disease

Study Purpose

A single arm study with resolute Onyx in One-Month DAPT for High-Bleeding Risk Patients who are considered One month Clear.

Principal Investigator: Dr. Srinivasa Potluri

Trial Details

Locations: THHBP, Baylor McKinney

Sponsor: Medtronic

IRB Number: 018-620

Trial Status: Enrolling

Exclusions: Pregnant and Breastfeeding women; Subjects requiring planned PCI 1 month of index procedure; Procedure planned to require non study stents, stand alone POBA, or stand alone artherectomy,; Active bleeding at time of inclusion,; Cardiogenic shock,; Subject with planned surgery or procedure necessitating discontinuation of DAPT within 1 month following index procedure; hypersensitivity or contraindication to aspirin/heparin/antiplatelet medications, drugs such as zotarolimus, cobalt, nickel, platinum, chromium, stainless steel; PCI during previous 6 monthsfor a lesion other than target lesion of the index procedure; participation in another study within 12 months after index procedure, subjects with life expectancy < 2 years

Change in Care: : Participating in this study will change your care in that you will have additional lab work, EKG and a clinic follow up visit

Contact Information:

Julie McCracken

Alexandria Biberstein

Full Protocol Title

Onyx ONE Clear: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One month Clear.

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