NL-OMON53694招募中不适用
Prospective randomized multi-center controlled clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion. - Occluflex
Occlutech US LLC0 个研究点目标入组 15 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
- 15
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
- •Subjects with a PFO and cryptogenic stroke:
- •PFO defined as visualization of microbubbles (during TEE) in the left atrium
- •within three cardiac cycles of right atrial opacification at rest and/or with
- •Cryptogenic stroke defined as a stroke of unknown cause.
- •Stroke defined as an acute focal neurological deficit, presumed to be due to
- •focal ischemia, and either:
- •o Symptoms persisting >=24 hours, or
- •o Symptoms persisting <24 hours with MR or CT findings of a new,
- •neuroanatomically relevant, cerebral infarct.
排除标准
- •Age <18 years
- •MI or unstable angina within 6 months
- •Mitral or aortic valve stenosis or severe regurgitation
- •LVEF <35%
- •Uncontrolled hypertension or diabetes mellitus despite medications
- •Subjects contraindicated for aspirin or clopidogrel
- •Subjects not able to discontinue anticoagulation
- •Qualifying stroke with Modified Rankin score >3
- •Anatomy in which the device would interfere with intracardiac or vascular
- •Life expectancy < 2 years
- •Exclusion for patients with known causes of ischemic stroke:
- •Atrial fibrillation/atrial flutter (chronic or intermittent)
- •LV aneurysm, intracardiac thrombus, or tumor
- •Mitral or aortic valve vegetation or prosthesis
- •Aortic arch plaques protruding >4 mm into the lumen
- •Atherosclerosis or arteriopathy of intra- or extracranial vessels with >50%
- •diameter stenosis in the artery supplying the infarcted territory
- •Another cause of right-to-left shunting (e.g., an ASD or a fenestrated atrial
- •Presence of an arterial hypercoagulable state:
- •o Lupus anticoagulant,
- •o anticardiolipin Abs,
- •o hyperhomocysteinemia,
- •o Cancer-related hypercoagulability.
- •Lacunar infarct probably due to intrinsic small vessel as the qualifying
- •event, defined as an ischemic stroke in the distribution of a single, small
- •deep penetrating vessel in a patient with any of the following:
- •o A history of hypertension (except in the first week post stroke)
- •o A history of diabetes mellitus
- •o Age >=50 years
- •o MRI or CT with leukoaraiosis greater than symmetric, well-defined
- •periventricular caps, or bands (European Task Force on Age-Related White Matter
- •Changes rating scale score >0)
- •Arterial dissection as the qualifying event
研究者
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