Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/5/2019 |
Start Date: | July 7, 2015 |
End Date: | December 3, 2018 |
A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx
Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native
coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.
Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native
coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.
Inclusion Criteria:
- Must be an acceptable candidate for percutaneous coronary intervention (PCI),
stenting, and emergent coronary artery bypass graft (CABG) surgery
- Must have clinical evidence of ischemic heart disease, stable or unstable angina,
and/or a positive functional study
- Must require treatment of either a) a single target lesion amenable to treatment OR b)
two target lesions located in separate target vessels
- Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
Exclusion Criteria:
- Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin,
thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer
coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately
pre-medicated
- History of an allergic reaction or significant sensitivity to drugs such as
zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- History of a stroke or transient ischemic attack (TIA) within the prior 6 months
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Concurrent medical condition with a life expectancy of less than 12 months
- Currently participating in an investigational drug or another device trial that has
not completed the primary endpoint
- Documented left ventricular ejection fraction (LVEF) < 30% at the most recent
evaluation
We found this trial at
12
sites
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials