Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Vascular
The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm
You may not be if
Within 7 days of index procedure platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; White Blood Cell (WBC) count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
Acute MI within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (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 Transient Ischemic Attack (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
