Coronary Artery Disease
Conditions
Brief summary
Post Market study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold
Interventions
DEVICEFantom
Treatment of den ovo coronary lesions
Sponsors
REVA Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure | 12 Months | TLF Composite defined by rate of Cardiac Death, Target Vessel MI and Ischemic Driven Target Lesion Revascularization |
Countries
Austria, Germany, Switzerland
Contacts
Primary ContactJeffrey Anderson
Outcome results
None listed