Absorb IV Randomized Controlled Trial

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., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:
• Unstable angina or NSTEMI within 2 weeks of the index procedure.
• STEMI > 72 hours ≤ 2 weeks prior to the index procedure.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

• Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and 72 hours but ≤ 2 weeks prior to the index procedure).
• Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
• Target lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

Note: To exclude enrollment of excessively small vessels, if the operator believes that based on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). This measurement may be performed before or after pre-dilatation, but before randomization. If the distal RVD measures 30 days before the index procedure, or between a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated.

• Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular interventions 700,000 cells/mm3.
• Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
• Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) 5 minutes.
• Any ST-segment depression or elevation lasting > 5 minutes.
• 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 to the LAD and/or LCX arteries is present), and there is no intention to treat the protected left main lesion).
• Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
• Lesion located within 3 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX).
• Lesion involving a bifurcation with a:
• side branch ≥ 2 mm in diameter, or
• side branch with either an ostial or non-ostial lesion with diameter stenosis >50%, or
• side branch requiring dilatation
• Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:
• Extreme angulation (≥ 90°) proximal to or within the target lesion.
• Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
• Moderate or heavy calcification proximal to or within the target lesion. If intravascular ultrasound (IVUS) used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
• Lesion or