Coronary Artery Disease Clinical Trial
— R-USOfficial title:
A Clinical Evaluation of the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2mm
Verified date | January 2016 |
Source | Medtronic Vascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.
Status | Active, not recruiting |
Enrollment | 1516 |
Est. completion date | June 2016 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
General and Angiographic Inclusion Criteria highlights: - Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery - Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study - Informed consent - Patient agrees to comply with specified follow-up evaluations at same investigational site - Single target lesion or two target lesions located in separate coronary arteries - De novo lesion(s) in native coronary artery(ies) - Target lesion(s) = 27 mm in length (or = 35 mm for a lesion to be treated with a 38 mm length stent) - Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent) General and Angiographic Exclusion Criteria highlights: - Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; WBC count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl - Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB > lab upper limit of normal) - Previous PCI of target vessel(s) within 9 months prior to the procedure - Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure - History of stroke or TIA within prior 6 months - Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints - Inability to comply with required trial antiplatelet regimen - Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent - Target vessel(s) has/have other lesions w/ > 40% diameter stenosis - Unprotected left main coronary artery disease |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | East Texas Medical Center | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
Medtronic Vascular |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target Lesion Failure (TLF) | Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods. | 12 Months | Yes |
Secondary | Target Vessel Failure (TVF) | Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods). | 12 months | Yes |
Secondary | Major Adverse Cardiac Event (MACE) | Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods). | 12 months | Yes |
Secondary | Death | 12 months | Yes | |
Secondary | Target Vessel MI | Target Vessel MI (as determined by extended historical and ARC definitions). | 12 months | Yes |
Secondary | Stent Thrombosis (ST) | Stent Thrombosis (ST) (as determined by historic and ARC definitions). | 12 months | Yes |
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