Medtronic Resolute Onyx 2.0 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: | April 6, 2015 |
End Date: | February 21, 2019 |
A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 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 that allows the use of a 2.0 mm diameter stent.
Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native
coronary arteries that allows the use of a 2.0 mm diameter stent.
Inclusion Criteria:
- Must be an acceptable candidate for percutaneous coronary intervention, stenting, &
emergent coronary artery bypass graft (CABG) surgery
- Must have evidence of ischemic heart disease
- Must require treatment of either a) a single target lesion amenable to treatment with
a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at
least one of the target lesions amenable to treatment with a 2.0 mm study stent
- 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
17
sites
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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