NL-OMON54360招募中不适用
Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting;Substudy: Characterization of Intermediate Lesions - DEFINE GPS;Substudy: ChI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Philips
- 入组人数
- 521
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
- •1. Adult men and women (local age of consent) who present with stable or
- •unstable angina, or NSTEMI.
- •2. Undergoing cardiac catheterization with planned or possible ad hoc PCI
- •3. Following angiography, PCI is indicated in at least one coronary artery* on
- •the basis of one or more of the following:
- •a. Presenting with NSTE-ACS (unstable angina with ECG changes or cardiac
- •enzyme-positive NSTEMI) with an identified culprit lesion with DS >=50%;
- •b. One or more angiographic stenoses present with >=80% stenosis severity by
- •visual estimation;
- •c. One or more angiographic stenoses present with >=50% to <80% stenosis
- •severity by visual estimation and an abnormal non-invasive stress test in the
- •distribution of the lesion(s) within the past 60 days;
- •d. One or more angiographic stenoses are present with >=50% to <80% stenosis
- •severity by visual estimation and a spot iFR measure <=0.89.
- •Note: Multiple target vessels may be present. However, all must be qualified by
- •all inclusion and exclusion criteria prior to randomization, and all qualified
- •vessels must be treated per the randomization assignment (e.g. all with
- •standard angiographic guidance or all with physiologic guidance). Non-culprit
- •vessels in patients with NSTE-ACS must qualify by one of the criteria listed in
- •b-d above.
- •Staged procedures are permitted as detailed below.
- •4. Subject is willing to comply with all scheduled visits and tests and are
- •able and have provided informed written consent
- •*May or may not be known prior to consent. If patient is consented and
- •following angiography all inclusion criteria are not present or any exclusion
- •criteria are present, the patient will not be randomized
- •For the substudy ChIL:
- •1. Adult men and women (local age of consent) who present with stable angina
- •2. Undergoing cardiac catheterization with planned or possible ad hoc PCI
- •3. Following angiography, at least one epicardial vessel has one or more
- •angiographic stenoses with >=50% to <80% stenosis severity by visual estimation
- •and a spot iFR measure > 0.89 or FFR > 0.80.
- •4. Subject is willing to comply with all procedure steps and has provided
- •informed written consent
排除标准
- •1. STEMI within 30 days
- •2. PCI within the prior 12 months, or any PCI planned after the study procedure
- •(other than planned staged procedures of randomized vessels which are allowed)
- •3. Prior CABG anytime
- •4. Silent ischemia only (i.e. no cardiac symptoms related to coronary artery
- •disease) within the prior 4 weeks
- •5. Documented prior iFR pullback performed in any coronary artery including
- •during the qualifying diagnostic angiogram
- •6. Any vessel with in-stent restenosis (ISR) requiring treatment
- •7. Cardiogenic shock defined as systolic blood pressure <90 mmHg for >20
- •minutes not responding to fluid resuscitation, or need for inotropic, pressor,
- •or device-based hemodynamic support
- •8. Presence of unstable ventricular arrhythmias
- •9. Heart rate > 110, including uncontrolled atrial fibrillation (AF)
- •10. Decompensated congestive heart failure (NYHA Class IV or Killip Class III
- •11. Chronic total occlusion (CTO) of a target vessel (exception: a CTO may be
- •present in a non-target vessel if it is supplying non-viable myocardium and
- •there is no intent to open the CTO during the index or later procedure)
- •12. Coronary anatomy not amenable to pressure wire manipulation due to extreme
- •tortuosity or complexity such that it is unlikely that a pressure wire could be
- •passed to the distal third of the three major epicardial coronary arteries
- •13. Any angiographic giant thrombus (i.e., thrombus length > 3x RVD at lesion)
- •14. Any target vessel with < TIMI III flow
- •15. Any target lesion with a reference vessel diameter (RVD) less than 2.25mm
- •except for within the side branch of a bifurcation lesion
- •16. Any non-target lesion with a reference vessel diameter (RVD) greater than
- •2.00mm that contains an >=80% stenosis and is not intended for treatment with PCI
- •17. Known severe aortic or mitral valve stenosis/insufficiency
- •18. Known non-cardiovascular comorbidity resulting in lifespan <24 months
- •19. Known left ventricular ejection fraction <=30%
- •20. Estimated creatinine clearance (MDRD formula) <30 mL/min/1.73m2 or on
- •21. Any cardiac or non-cardiac surgical procedure planned within 12 months
- •after enrollment, or any procedure planned within 6 months after enrollment
- •that would necessitate discontinuation of dual antiplatelet therapy
- •22. Known pregnancy or planning to become pregnant (women of child-bearing
- •potential must have a negative pregnancy test within 1 week of enrollment)
- •23. Participating in another investigational drug or device study that has not
- •reached its primary endpoint
- •24. Any condition such as dementia or substance abuse that may impair the
- •patient*s ability to comply with all study procedures, including medication
- •compliance and follow-up visits
- •25. Patient is a member of a vulnerable population who, in the judgment of the
- •investigator, is unable to give Informed Consent for reasons of incapacity,
- •immaturity, adverse personal circumstances or lack of autonomy. This may
- •include individuals with mental disability, persons in nursing homes, children,
- •impoverished persons, persons in emergency situations, homeless persons,
- •nomads, refugees, and those permanently incapable of giving informed consent.
- •Vulnerable populations also include university students, subordinate hospital
- •and laboratory personnel, employees of the Sponsor, members of the armed
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