Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions

General Inclusion Criteria:

1. 18 years of age.
2. Subject or a legally authorized representative must provide written Informed Consentprior to any study related procedure, per site requirements.
3. Evidence of myocardial. In the absence of noninvasive ischemia, FFR must be done andindicative of ischemia.
4. An acceptable candidate for coronary artery bypass graft (CABG) surgery.
5. Female subject of childbearing potential who does not plan pregnancy for up to 1 yearfollowing the index procedure.
6. Female subject is not breast-feeding at the time of the screening visit and will notbe breast-feeding for up to 1 year following the index procedure.
7. Subject agrees to not participate in any other investigational or invasive clinicalstudy for a period of 1 year following the index procedure. Angiographic Inclusion Criteria:
8. One or two de novo target lesions:
9. If two target lesions are present, they must be present in different epicardialvessels and both must satisfy the angiographic eligibility criteria.
10. The definition of epicardial vessels means the left anterior descending (LAD),left coronary artery (LCX), and right coronary artery (RCA) and their branches.Thus, the patient must not have lesions requiring treatment in e.g. both the LADand a diagonal branch.
11. Target lesion(s) must be located in a native coronary artery with a visually estimatedor quantitatively assessed % diameter stenosis (DS) of ≥ 50% and < 100% with athrombolysis in myocardial infarction (TIMI) flow of ≥ 1 and one of the following:stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve (FFR),stress test), unstable angina or post-infarct angina.
12. Lesion(s) must be located in a native coronary artery with reference vesseldiameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
13. Lesion(s) must be located in a native coronary artery with length by visualestimation of ≤ 24 mm.

General Exclusion Criteria:

1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or anAdenosine diphosphate receptor (ADP) antagonist is planned within 12 months after theprocedure.
2. Subject has known hypersensitivity or contraindication to device material and itsdegradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) andcobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannotbe adequately pre-medicated. Subject has a known contrast sensitivity that cannot beadequately pre-medicated.
3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin;or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, andtherefore cannot be adequately treated with study medications.
4. Subject had an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours ofthe index procedure and both creatine kinase (CK) and creatine kinase myocardial-bandisoenzyme (CK-MB) have not returned to within normal limits at the time of indexprocedure; or subject with stable angina or silent ischemia has CK-MB that is greaterthan normal limits at the time of the index procedure.
5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECGchanges.
6. Subject has a cardiac arrhythmia as identified at the time of screening for which atleast one of the following criteria is met:
7. Subject requires coumadin or any other agent for chronic oral anticoagulation
8. Subject is likely to become hemodynamically unstable due to their arrhythmia
9. Subject has poor survival prognosis due to their arrhythmia
10. Subject has a left ventricular ejection fraction (LVEF) < 30%
11. Subject has undergone prior percutaneous coronary intervention (PCI) within the targetvessel(s) during the last 12 months.
12. Subject requires future staged PCI either in target or non-target vessels or subjectrequires future peripheral interventions < 30 days after the index procedure.
13. Subject has received any solid organ transplants or is on a waiting list for any solidorgan transplants.
14. At the time of screening, the subject has a malignancy that is not in remission.
15. Subject is receiving immunosuppressant therapy or has known immunosuppressive orsevere autoimmune disease that requires chronic immunosuppressive therapy (e.g., humanimmunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids arenot included as immunosuppressant therapy.
16. Subject has previously received or is scheduled to receive radiotherapy to a coronaryartery (vascular brachytherapy), or the chest/mediastinum.
17. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin,dabigatran, apixaban, rivaroxaban or any other agent for any reason).
18. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
19. Subject has a documented or suspected hepatic disorder as defined as cirrhosis orChild-Pugh ≥ Class B.
20. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
21. Subject is high risk of bleeding for any reason; has a history of bleeding diathesisor coagulopathy; has had a significant gastro-intestinal or significant urinary bleedwithin the past six months.
22. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanentneurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenousmalformation, etc.).
23. Subject has extensive peripheral vascular disease that precludes safe 6 French sheathinsertion. Note: femoral arterial disease does not exclude the patient if radialaccess may be used.
24. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.
25. Subject is in the opinion of the Investigator or designee, unable to comply with therequirements of the study protocol or is unsuitable for the study for any reason.
26. Subject is currently participating in another clinical trial that has not yetcompleted its primary endpoint.
27. Subject is part of a vulnerable population Angiographic Exclusion Criteria: All exclusion criteria apply to the target lesion(s) or target vessel(s).
28. Lesion which prevents successful balloon pre-dilatation
29. Lesion is located in left main.
30. Aorto-ostial RCA lesion.
31. Lesion located within 3 mm of the origin of the LAD or LCX.
32. Lesion involving a bifurcation with a:
33. side branch ≥ 2 mm in diameter, or
34. side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or
35. side branch requiring dilatation.
36. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS.
37. Vessel contains thrombus as indicated in the angiographic images or by intravascularultrasound (IVUS) or optical coherence tomography (OCT).
38. Lesion or vessel involves a myocardial bridge.
39. Vessel has been previously treated with a stent at any time prior to the indexprocedure such that the Absorb BVS would need to cross the stent to reach the targetlesion.
40. Vessel has been previously treated and the target lesion is within 5 mm proximal ordistal to a previously treated lesion.
41. Target lesion located within an arterial or saphenous vein graft or distal to anyarterial or saphenous vein graft.