A Clinical Investigation to Assess the Abbott Next Generation Drug Eluting Stent 48mm Everolimus Eluting Coronary Stent System (EECSS) in Treatment of de Novo Native Coronary Artery Disease
The purpose of this SPIRIT 48 study is to evaluate the safety and effectiveness of the ABT NG DES 48 in improving coronary artery luminal diameter in subjects with coronary artery disease (CAD) due to de novo native coronary artery long lesions.
• Subject must be at least 18 years of age.
• Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
• Subject must have evidence of myocardial ischemia (e.g., unstable angina, post-infarct angina, stable angina or silent ischemia) suitable for non-emergent PCI. Subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following,
‣ Abnormal stress or imaging stress test
⁃ Abnormal computed tomography-fractional flow reserve (CT-FFR)
⁃ Stenosis by visual estimation ≥ 70%
⁃ Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio \[iFR\], or relative flow reserve \[RFR\])
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
• Angiographic Inclusion Criteria:
• Only one de novo target lesion in native coronary artery is allowed to be treated with the investigational stent.
• • One additional non-target lesion can be treated if it is located in a different epicardial coronary vessel and NOT in left main coronary artery. The non-target lesion must be treated first and must be deemed an angiographic success.
• The target lesion must be located in a native coronary artery with:
‣ Visually estimated reference vessel diameter (RVD) of ≥ 2.5 mm and ≤ 4.25 mm.
⁃ Visually estimated lesion length of \> 32 mm and ≤ 44 mm, and able to be covered by a single ABT NG DES 48.
‣ a. Multiple focal de novo lesions in an epicardial coronary vessel are allowed if the lesions can be covered by one stent. Multiple focal de novo lesions will be counted as a single lesion.
⁃ Visually estimated diameter stenosis of \> 50% and \< 100% with a Thrombolysis in Myocardial Infarction (TIMI) flow of ≥ 1
∙ Stable angina or silent ischemia subjects must have stenosis ≥ 70%, or abnormal pressure-derived physiological indices (FFR, iFR, or RFR), unless abnormal stress or imaging stress test is evidenced.