NL-OMON55419已完成不适用
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold - FANTOM II Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* The patient is * 18 years of age
- •* The subject must have evidence of myocardial ischemia (e.g. stable, unstable
- •angina, post-infarct angina or silent ischemia) suitable for elective PCI.
- •Subjects with stable angina or silent ischemia and < 70% diameter stenosis must
- •have objective signs of ischemia as determined by one of the following:
- •echocardiogram, nuclear scans, ambulatory ECG or stress ECG. In the absence of
- •noninvasive ischemia, FFR must be done and must be indicative of 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 prior to the
- •* Each lesion must meet all the following baseline criteria (prior to
- •pre-dilation):
- •- De novo lesion in a native coronary artery
- •- Visually estimated stenosis of * 50% and <100%
- •- Visually estimated RVD * 2.5 mm and * 3.5 mm
- •- Lesion length * 20 mm by visual estimate
- •- Baseline TIMI flow * 2 per visual estimate
- •* During pre-dilatation the pre-dilatation balloon is uniformly expanded to the
- •full intended diameter
- •* Immediately after the pre-dilatation process the patient does not experience
- •chest pain or ECG changes lasting longer than 10 minutes
- •* Each lesion must meet all the following criteria after pre-dilatation:
- •- Visually estimated stenosis of * 40%
- •- Target vessel reference diameter * 2.5 mm and * 3.5 mm by QCA, IVUS or OCT
- •- Lesion length * 20 mm by visual estimate
- •- Post pre-dilatation TIMI flow * 3 per visual estimate
- •- No dissections * type C
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 myocardial infarction (AMI: STEMI or
- •NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not
- •returned to within 2X ULN. Note: In the event that CK-MB is not measured prior
- •to treatment, the patient will be considered to have met this enrollment
- •criteria provided that the Troponin assessment is within 2X ULN and a blood
- •sample is drawn prior to the procedure; the CK-MB analysis must then be
- •performed post-procedure
- •* The patient is currently experiencing clinical symptoms consistent with AMI
- •* The patient has a left ventricular ejection fraction of <40%
- •* The patient requires or has had an additional intervention of a coronary
- •lesion in the target vessel within 1 year of the index procedure
- •* The patient requires additional intervention of another coronary lesion in
- •the target epicardial vessel (LAD, LCX or RCA) or branch of the target
- •epicardial vessel during the index procedure
- •Note: Staged procedures to treat lesions in non-target epicardial vessels are
- •allowed during the index procedure or > 30 days after REVA scaffold
- •implantation. If a non-target lesion requires treatment during the index
- •procedure, the non-target lesion should be treated first
- •* The patient has unprotected left main coronary disease with * 50% stenosis
- •* The patient has a significant (* 50%) untreated stenosis proximal or distal
- •to the target lesion
- •* The patient has a scaffold(s) or 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
- •REVA 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 completed the entire follow-up period
- •* The patient has a co-morbidity, which reduces life expectancy to * 24 months,
- •or factors making clinical follow-up difficult
- •* The patient has:
- •- Known hepatic impairment (Liver function tests (SGOT, SGPT, and ALT) >3 times
- •- Known impaired renal function (serum creatinine * 2.5 mg/dL)
- •- A platelet count <100,000 cells/mm3 (thrombocytopenia); and/or >700,000
- •* The patient has a history of stroke (CVA) or TIA within the prior 6 months
- •* The patient has an active peptic ulcer or upper GI bleeding within the prior
- •* 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
- •* Target lesion ostial (within 3mm of vessel origin)
- •* Target lesion has moderate to severe calcification
- •* Target segment has side branches or a bifurcation > 1.5 mm in diameter
- •* Target lesion is located within an arterial bypass graft conduit or saphenous
- •* Target lesion is located within a previously stented region
- •* Target lesion is located within a segment supplied by distal graft
- 另有 2 项未显示
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