| Eligibility |
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, both
heparin and bivalirudin, clopidogrel and/or contrast media, and cannot be adequately
pre-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 not returned
to within ULN (Note: the patient with a recent NSTEMI with elevated biomarkers 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 12
months.
- 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 a
non-target vessel is acceptable if performed anytime > 30 days before the index
procedure or between a minimum of 24 hours and 30 days before the index procedure is
successful 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 lesion
identified at the time of the index procedure.
- The patient has received any solid organ transplant or is on a waiting list for any
solid 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 or
severe 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 lesion
angulation, such that in the operator's judgment it is unlikely that the Fantom
Bioresorbable Coronary Scaffold or a standard scaffold could be delivered and/or
expanded.
- The patient is currently participating in another investigational drug or device trial
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 this
protocol.
The patient has:
- Known hepatic impairment (liver function tests (SGOT, SGPT, or ALT) >3 times normal);
- 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 any
permanent neurologic defect, or any prior history of intracerebral bleeding.
- The patient has an active peptic ulcer or upper GI bleeding within the prior 6 months.
- The patient has a history of bleeding diathesis or coagulopathy or will refuse blood
transfusions.
- The patient is a woman that is pregnant or lactating or is planning to get pregnant
during the follow-up period of this trial. Note: Women of child-bearing potential
should 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 in the
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 with
diameter stenosis >50% or requiring dilation
- Target lesion is located within an arterial bypass graft conduit or saphenous vein
graft.
- 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 reason
is present which might require discontinuing aspirin and/or clopidogrel within 1 year
of the Fantom scaffold implantation
- Patient has a known allergy to tyrosine derived polycarbonate or Sirolimus and its
structurally related compounds.
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