NL-OMON50216招募中不适用
Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect - Combined pressure and Doppler FLOW velocity measurements - DEFINE FLOW
niversity of Texas Medical School at Houston0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- •3.1 Inclusion Criteria, 3.1.1 Age >= 18 years., 3.1.2 Eligible for PCI based on
- •local practice standards during the current procedure (PCI cannot be staged).,
- •3.1.3 At least one epicardial stenosis of >=50% diameter (by visual or
- •quantitative assessment) and meeting the following criteria as determined by
- •the operator based on either a prior or the current diagnostic angiogram:
- •<100% diameter (not a chronic, total occlusion);
- •in a native coronary artery (including side branches but excludes bypass
- •of >=2.5mm reference diameter (near the level of the stenosis);
- •and supplies sufficiently viable myocardium (exclude regions of known, prior,
- •transmural myocardial infarction)., 3.1.4 Ability to understand and the
- •willingness to sign a written informed consent.
排除标准
- •Anatomic exclusions:, 3.2.1 Prior CABG., 3.2.2 Preferred treatment strategy for
- •revascularization would be CABG based on local practice standards., 3.2.3 Left
- •main coronary artery disease requiring revascularization., 3.2.4 Extremely
- •tortuous or calcified coronary arteries precluding intracoronary physiologic
- •measurements. Operators may also exclude subtotal or similar high-grade
- •lesions, which in their judgment may be threatened by ComboWire placement.,
- •3.2.5 Known severe LV hypertrophy (septal wall thickness at echocardiography of
- •>13 mm)., Clinical exclusions:
- •3.2.6 Inability to receive intravenous adenosine (for example, severe reactive
- •airway disease, marked hypotension, or high-grade AV block without pacemaker).,
- •3.2.7 Recent (within 3 weeks prior to cardiac catheterization) ST-segment
- •elevation myocardial infarction (STEMI) in any arterial distribution (not
- •specifically target lesion)., 3.2.8 Culprit lesions (based on clinical judgment
- •of the operator) for either STEMI or non-STEMI cannot be included., 3.2.9
- •Severe cardiomyopathy (LV ejection fraction <30%)., 3.2.10 Planned need for
- •cardiac surgery (for example, valve surgery, treatment of aortic aneurysm, or
- •septal myomectomy)., General exclusions:
- •3.2.11 A life expectancy of less than 2 years., 3.2.12 Inability to sign an
- •informed consent, due to any mental condition that renders the subject unable
- •to understand the nature, scope, and possible consequences of the trial or due
- •to mental retardation or language barrier., 3.2.13 Potential for non-compliance
- •towards the requirements for follow-up visits., 3.2.14 Participation or planned
- •participation in another cardiovascular clinical trial before completing the 24
- •month follow-up.
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