FANTOM Post Market Clinical Trial

Inclusion Criteria:

• The patient is at least 18 years of age.

• The subject must have evidence of myocardial ischemia

• The patient is an acceptable candidate for PTCA, stenting and emergent CABG.

• The patient is willing and able to comply with the specified follow-up evaluations.

• The patient's written informed consent has been obtained.

Each lesion to be treated with Fantom must meet all the following baseline criteria:

• De novo lesion in a native coronary artery

• Visually estimated stenosis of > or equal to 50% and <100%.

• Visually estimated RVD > or equal to 2.5 mm and less than or equal to 3.75 mm.

• Baseline TIMI flow greater than or equal to 2 per visual estimate.

• Lesion Length less than or equal to 20 mm, able to be covered by a single scaffold

• No angiographic complications (e.g. distal embolization, side branch closure).

• No dissections greater than or equal to NHLBI type C.

• Patient has no ongoing chest pain or ECG ST-segment of T-wave changes.

Exclusion Criteria:

• The patient has a known allergy, intolerance, or is contraindicated to aspirin, bothheparin and bivalirudin, clopidogrel and/or contrast media, and cannot be adequatelypre-medicated.

• The patient has experienced an acute ST-segment elevation myocardial infarction (AMI: STEMI) within 72 hours of the procedure and either CK-MB or Troponin has notreturned to within ULN (Note: the patient with a recent NSTEMI with elevatedbiomarkers may still be enrolled).

• The patient has a left ventricular ejection fraction of <30%.

• The patient has unprotected left main coronary disease with greater than or equal to 50% stenosis.

• The patient has undergone prior PCI within the target vessel during the last 12months.

• Prior PCI of a non-target vessel within 24 hours prior to the procedure, or within 30 days prior to the procedure if unsuccessful or complicated. Note: Prior PCI of anon-target vessel is acceptable if performed anytime > 30 days before the indexprocedure or between a minimum of 24 hours and 30 days before the index procedure issuccessful and uncomplicated.

• Prior PCI within 3 years with a bioresorbable scaffold in any vessel.

• The patient requires future staged PCI of any lesion other than a target lesionidentified at the time of the index procedure.

• The patient has received any solid organ transplant or is on a waiting list for anysolid organ transplant.

• At the time of screening, the subject has a malignancy that is not in remission.

• The patient is receiving immunosuppressant therapy or has known immunosuppressive orsevere autoimmune disease that requires chronic immunosuppressive therapy.

• The patient has a stent located within 3 mm of the target lesion borders.

• The target vessel is totally occluded (TIMI Flow 0 to 1).

• Excessive proximal tortuosity, vessel hinging at the lesion location or lesionangulation, such that in the operator's judgment it is unlikely that the FantomBioresorbable Coronary Scaffold or a standard scaffold could be delivered and/orexpanded.

• The patient is currently participating in another investigational drug or devicetrial that has not reached its primary endpoint assessment

• The patient has co-morbidities which reduce life expectancy to less than or equal to 24 months, or a condition that may interfere with the follow-up procedures of thisprotocol.

The patient has:

• Known hepatic impairment (liver function tests (SGOT, SGPT, or ALT) >3 timesnormal);

• Known impaired renal function (serum creatinine greater than or equal to 2.5 mg/dL).

• A platelet count <100,000 cells/mm3 and/or >700,000 cells/mm3

• The patient has a history of stroke (CVA) or TIA within the prior 6 months, or anypermanent neurologic defect, or any prior history of intracerebral bleeding.

• The patient has an active peptic ulcer or upper GI bleeding within the prior 6months.

• The patient has a history of bleeding diathesis or coagulopathy or will refuse bloodtransfusions.

• The patient is a woman that is pregnant or lactating or is planning to get pregnantduring the follow-up period of this trial. Note: Women of child-bearing potentialshould have a negative pregnancy test before enrollment.

• Target lesion ostial (within 3mm of vessel origin).

• Target lesion is located in the left main or there is a > 30% diameter stenosis inthe left main artery

• Target lesion has moderate to severe calcification.

• Target segment(s) has one or more side branches >2.0 mm in diameter.

• Target segment(s) has a side branch with either an ostial or non-ostial lesion withdiameter stenosis >50% or requiring dilation

• Target lesion is located within an arterial bypass graft conduit or saphenous veingraft.

• Target lesion is located within a previously stented region.

• Target lesion is located within a segment supplied by distal graft.

• Target lesion has possible or definite thrombus.

• The patient is currently receiving or will require chronic anticoagulation therapy (e.g. coumadin, dabigatran, apixaban, rivaroxaban, or edoxaban for any reason).

• The patient is known to need or has a planned surgical procedure or any other reasonis present which might require discontinuing aspirin and/or clopidogrel within 1year of the Fantom scaffold implantation

• Patient has a known allergy to tyrosine derived polycarbonate or Sirolimus and itsstructurally related compounds.