Elixir Medical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - Cx Registry

- Patient must be at least 18 years of age and for the 35-patient subset, patients must be over the age of 50

- Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) and he/she provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure

- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia)

- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery

- Patient must agree to undergo all clinical study required follow-up visits, angiograms, and as applicable, imaging testing

- Patient must agree not to participate in any other clinical study for a period of two years following the index procedure

- Target lesion must be located in a native coronary artery with a nominal vessel

- Not part of a clinical investigation

- Treatment of a single, non-target lesion located in a separate major epicardial vessel Target vessel diameter must be a diameter of between 2.25 and 3.5 mm assessed by online QCA

- Target lesion must measure ≤ 24 mm in length

- Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 90% with a TIMI flow of ≥ 1

- Target vessel must be in a major coronary artery or major branch

- Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and cardiac enzymes have not returned within normal limits at the time of procedure

- Patient is currently experiencing clinical symptoms consistent with AMI

- Patient requires the use of any rotablator intervention during the index procedure

- Patient has current unstable arrhythmias

- Patient has a known left ventricular ejection fraction (LVEF) < 30%

- Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant

- Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure

- Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)

- Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures.

- Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Novolimus, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated

- Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel

- Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease.

- Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)

- Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

- Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months

- Patient has had a significant GI or urinary bleed within the past six months

- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion

- Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)

- Patient is already participating in another clinical study

- Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing

- Patient is unable to give their consent, is legally incompetent, or is institutionalized by virtue of an order issued by the courts or other authority

- Target lesion(s) meets any of the following criteria:

- Aorto-ostial location

- Left main location

- Located within 5 mm of the origin of the LAD or LCX

- Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft

- Lesion involving a side branch >2mm in diameter or bifurcation

- Previous placement of a scaffold proximal to or within 10 mm of the target lesion

- Total occlusion (TIMI flow 0), or TIMI flow < 1

- Excessive tortuosity proximal to or within the lesion

- Angulation (≥ 45o) proximal to or within the lesion

- Calcification moderate or heavy

- Previous intervention restenosis

- The target vessel contains visible thrombus

- Another clinically significant lesion (>40%) is located in the same major epicardial vessel as the target lesion

- Patient has a high probability that a procedure other than pre-dilatation and scaffolding and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)