Absorb IV Randomized Controlled Trial

General Inclusion Criteria:

1. Subject must be at least 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. Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable orunstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevationMI (STEMI). Patients with stable coronary syndromes can be enrolled any time aftersymptom onset if eligibility criteria are otherwise met. Patients with acute coronarysyndrome can be enrolled under the following conditions:
4. Unstable angina or NSTEMI within 2 weeks of the index procedure.
5. STEMI > 72 hours ≤ 2 weeks prior to the index procedure. Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of theindex procedure can be included in the trial but should be categorized based on theircurrent angina class.
6. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective signs of ischemia as determined by one ofthe following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG),positron emission tomography (PET), magnetic resonance imaging (MRI), and/orfractional flow reserve (FFR). (Note: subject with silent ischemia must have a prior history of typical angina,angina-equivalent symptoms, or atypical angina within the past year to be included inthe trial.)
7. Subject must be an acceptable candidate for coronary artery bypass graft (CABG)surgery.
8. Female subject of childbearing potential who does not plan pregnancy for up to 1 yearfollowing the index procedure. For a female subject of childbearing potential apregnancy test must be performed with negative results known within 7 days prior tothe index procedure per site standard.
9. Female subject is not breast-feeding at the time of the screening visit and will notbe breast-feeding for at least 1 year following the index procedure.
10. Subject agrees to not participate in any other investigational or invasive clinicalstudy for a period of 5 years following the index procedure. Angiographic Inclusion Criteria: Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with amaximum of two lesions per epicardial vessel. If only a single lesion is to be treated, itmust be a target lesion. Up to one non-target lesion can be treated. Non-target lesiontreatment can occur only in a non-target vessel. If there are two target lesions within the same epicardial vessel, the two target lesionsmust be at least 15 mm apart per visual estimation; otherwise this is considered as asingle target lesion for lesion (and stent) length determination and must be treated with asingle study device.
11. Target lesion(s) must be located in a native coronary artery with a visually estimatedor quantitatively assessed %DS of ≥50% and < 100%, with a thrombolysis in myocardialinfarction (TIMI) flow of ≥ 1, and one of the following: stenosis ≥ 70%, an abnormalfunctional test (e.g., fractional flow reserve ≤0.80 AND/OR a positive stress test), orpresentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks ofindex procedure, or STEMI >72 hours but ≤ 2 weeks prior to the index procedure).
12. Target 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. Target lesion(s) must be located in a native coronary artery with length by visualestimation of ≤ 24 mm. Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of theindex procedure can be included in the trial but should be categorized based on theircurrent angina class. Note: To exclude enrollment of excessively small vessels, if the operator believes thatbased on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mmsuch that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, itis strongly recommended that either on-line QCA or intravascular imaging (ultrasound oroptical coherence tomography) is used and demonstrates that the measured distal RVD forthis target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). Thismeasurement may be performed before or after pre-dilatation, but before randomization. Ifthe distal RVD measures <2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such alesion may be treated as a non-target lesion.

General Exclusion Criteria:

1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12receptor inhibitor is planned within 12 months after the procedure.
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 any ofthe following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin andbivalirudin, and therefore cannot be adequately treated with study medications.
4. Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segmentelevation in ≥2 contiguous leads) within 72 hours of the index procedure.
5. Subject has a cardiac arrhythmia identified at the time of screening for which atleast one of the following criteria is met:
6. Subject requires coumadin or any other agent for chronic oral anticoagulation.
7. Subject is likely to become hemodynamically unstable due to their arrhythmia.
8. Subject has poor survival prognosis due to their arrhythmia.
9. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by anyquantitative method, including but not limited to echocardiography, MRI,multiple-gated acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc.LVEF may be obtained within 6 months prior to the procedure for subjects with stableCAD. For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessedwithin 1 week of the index procedure and after ACS presentation, which may includecontrast left ventriculography during the index procedure but prior to randomizationin order to confirm the subject's eligibility.
10. Subject has undergone prior PCI within the target vessel during the last 12 months.Prior PCI within the non-target vessel or any peripheral intervention is acceptable ifperformed anytime >30 days before the index procedure, or between a minimum of 24hours and 30 days before the index procedure if successful and uncomplicated.
11. Subject requires future staged PCI of any lesion other than a target lesion identifiedat the time of index procedure; or subject requires future peripheral vascularinterventions < 30 days after the index procedure.
12. Subject has received any solid organ transplants or is on a waiting list for any solidorgan transplants.
13. At the time of screening, the subject has a malignancy that is not in remission.
14. 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.
15. Subject has previously received or is scheduled to receive radiotherapy to a coronaryartery (vascular brachytherapy), or the chest/mediastinum.
16. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin,dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for anyreason).
17. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
18. Subject has a documented or suspected hepatic disorder as defined as cirrhosis orChild-Pugh ≥ Class B.
19. 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.
20. Subject is high risk of bleeding for any reason; has a history of bleeding diathesisor coagulopathy; has had a significant gastrointestinal or significant urinary bleedwithin the past six months.
21. 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.).
22. 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.
23. Subject has a life expectancy <5 years for any non-cardiac or cardiac cause.
24. 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. Thisincludes completion of Patient Reported Outcome instruments.
25. Subject is currently participating in another clinical trial that has not yetcompleted its primary endpoint.
26. Subject is part of a vulnerable population who, in the judgment of the investigator,is unable to give Informed Consent for reasons of incapacity, immaturity, adversepersonal circumstances or lack of autonomy. This may include: Individuals with amental disability, persons in nursing homes, children, impoverished persons, personsin emergency situations, homeless persons, nomads, refugees, and those incapable ofgiving informed consent. Vulnerable populations also may include members of a groupwith a hierarchical structure such as university students, subordinate hospital andlaboratory personnel, employees of the Sponsor, members of the armed forces, andpersons kept in detention. Angiographic Exclusion Criteria: All exclusion criteria apply to the target lesion(s) or target vessel(s).
27. Unsuccessful pre-dilatation, defined as the presence of one or more of the following (note: successful pre-dilatation of at least one target lesion is required prior torandomization):
28. Residual %diameter stenosis (DS) after pre-dilatation is ≥ 40% (per visualestimation). Note: achieving a %DS ≤ 20% prior to randomization is stronglyrecommended.
29. TIMI flow grade <3 (per visual estimation).
30. Any angiographic complication (e.g. distal embolization, side branch closure).
31. Any dissection NHLBI grade D-F.
32. Any chest pain lasting > 5 minutes.
33. Any ST-segment depression or elevation lasting > 5 minutes.
34. Lesion is located in left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft tothe LAD and/or LCX arteries is present), and there is no intention to treat theprotected left main lesion).
35. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
36. Lesion located within 3 mm of the origin of the left anterior descending artery (LAD)or left circumflex artery (LCX).
37. Lesion involving a bifurcation with a:
38. side branch ≥ 2 mm in diameter, or
39. side branch with either an ostial or non-ostial lesion with diameter stenosis >50%, or
40. side branch requiring dilatation
41. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS orXIENCE stent:
42. Extreme angulation (≥ 90°) proximal to or within the target lesion.
43. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
44. Moderate or heavy calcification proximal to or within the target lesion. Ifintravascular ultrasound (IVUS) used, subject must be excluded if calcium arc inthe vessel prior to the lesion or within the lesion is ≥ 180°.
45. Lesion or vessel involves a myocardial bridge.
46. Vessel has been previously treated with a stent and the target lesion is within 5 mmproximal or distal to a previously stented lesion.
47. Target lesion located within an arterial or saphenous vein graft or distal to anyarterial or saphenous vein graft.