Abbott Next Generation Drug Eluting Stent 48mm Study

General Inclusion Criteria:

• 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 700,000 cells/mm^3.
• Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) 5 minutes.
• Any ST-segment depression or elevation lasting > 5 minutes.
• Side branch requires additional dilatation/stenting caused by plaque shift, carina shift or may require additional dilatation/stenting after stent implantation, per the operator's assessment.
• Non-target lesion meets any of the following criteria:
• Is located in the target vessel
• Is located in the left main location
• Is restenotic from a previous stent implantation
• Is located within a saphenous vein graft or an arterial graft
• Is with a TIMI flow 0 (total occlusion) prior to guide wire crossing
• Involves a complex bifurcation that needs two-stent strategy.
• Treatment of non-target lesion is not deemed successful.

Note: A successful treatment is defined as a treatment resulted in a mean lesion diameter stenosis < 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.