NCT03587922招募中不适用
Post Market Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 11
- 主要终点
- Target Lesion Failure
研究概览
简要总结
Post Market study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Target Lesion Failure
时间窗: 12 Months
TLF Composite defined by rate of Cardiac Death, Target Vessel MI and Ischemic Driven Target Lesion Revascularization
次要结局
未报告次要终点
研究者
研究点 (11)
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