Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

Inclusion Criteria:

- Age > 19 years

- Ability to give informed consent

- Documented stable CAD with a significant lesion in a native coronary artery amenable
to PCI with one stent

- Planned single vessel intervention

Exclusion Criteria:

- Myocardial infarction or unstable angina within the prior 7 days

- Target lesion is a chronic total occlusion (present for longer than 3 months)

- Target lesion with angiographically visible thrombus or in-stent thrombosis

- Target lesion is in a bypass graft

- Planned use of a GP IIb/IIIa inhibitor or planned use of atherectomy including
directional, rotational, or laser

- Known allergies or sensitivities to heparin, pork, or pork-containing products

- History of HIT

- Hemodynamic instability

- Stroke or Transient Ischemic Attack (TIA) in the prior 3 months

- Active bleeding or bleeding diathesis

- Trauma or major surgery in the preceding month or planned surgery or PCI within the 30
days after the index PCI

- Suspected aortic dissection

- Receiving oral anticoagulation therapy

- Receipt of LMWH or of UFH (except for that used during the diagnostic portion of the
index procedure) within the prior 7 days

- ACT > 200 prior to study drug administration

- Severe, untreated hypertension at the time of the index PCI procedure (systolic blood
pressure of > 180 mm Hg, diastolic blood pressure > 90 mm Hg)

- Hemoglobin level of less than 10.0 g/dl or a hematocrit below 30%

- Platelet count of less than 100,000 per cubic millimeter or more than 600,000 per
cubic millimeter

- Creatinine clearance < 30 mL/min

- Any malignancy within the prior 5 years with the exception of non-melanoma skin
cancers

- Prior enrollment in EMINENCE trial or currently receiving other experimental therapy

- Pregnant or lactating if subject is female

Substudy:

Inclusion:

- Ability to give informed consent

- Participation in the main study protocol

Exclusion:

-Inability to provide the blood specimens required by the substudy protocol