NL-OMON49764已完成不适用
Radiographic imaging Validation and EvALuation for Angio iFR (ReVEAL iFR) - ReVEAL iFR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Philips
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. *18 years old
- •2. At least 1 de-novo lesion in 1 or more major epicardial vessels of 40-90%
- •angiographic stenosis with a reference vessel size *2.5mm in the diseased
- •segment by visual estimate
- •3. Able and willing to provide informed consent
排除标准
- •1. Presenting with an acute coronary syndrome (ACS), or documented ACS within 4
- •weeks prior to the scheduled index procedure
- •2. Cardiogenic shock (sustained (>10 min) systolic blood pressure <90 mmHg in
- •absence of inotropic support or the presence of an intra-aortic balloon pump)
- •3. Presence of cardiac arrhythmias (e.g., atrial fibrillation, AV-block)
- •4. Prior cardiac surgery or implant, including CABG, heart transplant, surgical
- •heart valve replacement or repair, TAVI/TAVR, presence of an ICD or pacemaker
- •5. Target vessel supplied by a left main coronary artery demonstrating any
- •disease present (isolated or non-isolated)
- •6. Target vessel supplied by right coronary artery demonstrating any ostial
- •disease (located immediately at the origin of the coronary vessels from the
- •7. Target vessel with Chronic Total Occlusion (CTO) in the ipsilateral
- •territory or target vessel with an untreated CTO in the contralateral
- •territory. Note: if a CTO existing in the contralateral territory is
- •successfully opened, the target vessel in the contralateral territory can be
- •included following CTO treatment.
- •8. Target vessel with severe tortuosity (*1 bends of 90° or more, or *3 or more
- •bends of 45°- 90° proximal to the diseased segment)
- •9. Target vessel with heavy calcification (multiple persisting opacifications
- •of the coronary wall visible in more than one projection surrounding the
- •complete lumen of the coronary artery at the site of the lesion.)
- •10. Target vessel with TIMI flow grade 1 or 0
- •11. Target vessel with severe diffuse disease (more than 75% of the length of
- •the segment having a vessel diameter of 2mm, irrespective of the presence or
- •absence of a lesion)
- •12. Target lesion is at a bifurcation/trifurcation
- •13. Target arteries supplying akinetic or severely hypokinetic territories if
- •already known based on prior imaging
- •14. Target vessel is supplied by major collaterals
- •15. Target stenosis associated with myocardial bridge
- •16. Any vascular abnormality precluding optimal contrast opacification (e,g,
- •thrombus, ulceration)
- •17. Severe aortic or mitral valve disease
- •18. Known ejection fraction *30%
- •19. Known severe renal insufficiency (eGFR<30ml/min/1.72m2)
- •20. Any fluoroscopic interference that renders the wire position unclear
- •21. Contraindication for adenosine or other hyperemic agent (e.g., caffeine
- •ingestion *18 hours, COPD, hypotension, AV block)
- •22. Known pregnancy or planning to become pregnant
- •23. Participating in another interventional investigational study that may
- •acutely impact microvascular function at the time of the physiology procedure
研究者
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