FANTOM Post Market Clinical Trial

Study Overview
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Brief Summary
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Post Market study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold

Official Title
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Post Market Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Fantom


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Single arm study with treatment of Fantom scaffold | Device: Fantom<br>* Treatment of den ovo coronary lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure | TLF Composite defined by rate of Cardiac Death, Target Vessel MI and Ischemic Driven Target Lesion Revascularization | 12 Months |