fantom post market clinical trial

Conditions: Coronary Artery Disease

Summary: post market study of the fantom sirolimus-eluting bioresorbable coronary scaffold


Eligibility criteria:
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 \ 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.