DESolve Post-Approval Study

POST-MARKET EVALUATION OF DESolve® NOVOLIMUS ELUTING BIORESORBABLE CORONARY SCAFFOLD SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS

To evaluate the long-term safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System

DESolve is not currently approved for sale in the United States.

Inclusion Criteria:

• Patient must be at least 18 years of age
• Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve NE 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
• Patient must agree not to participate in any other clinical study for a period of two years following the index procedure

Angiographic Inclusion Criteria - Target Lesion/Vessel Target lesion must be located in a native coronary artery with a nominal vessel diameter of between 2.75 and 3.5 mm assessed by visual estimation or 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
• Percutaneous intervention of lesions in the target vessel if:
• Not part of a clinical investigation
• ≥ 6 months prior to the study index procedure
• ≥ 9 months after the study index procedure (planned)
• Previous intervention was distal to and > 10 mm from the target lesion

Exclusion Criteria:

• Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB 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)
• 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

Angiographic Exclusion Criteria - Target Lesion/Vessel

• 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 sub-total occlusion (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