FANTOM Post Market Clinical Trial

This is an interventional treatment trial for Coronary Artery Disease Read More

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.