NL-OMON54677已完成不适用
OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI - ILUMIEN IV: OPTIMAL PCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,096
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. Subject must be at least 18 years of age.
- •2. Subject must have evidence of myocardial ischemia (e.g., stable angina,
- •silent ischemia, unstable angina, or acute myocardial infarction) suitable for
- •elective PCI.
- •3. Patients undergoing planned XIENCE stent implantation during a clinically
- •indicated PCI procedure meeting one or more of the following criteria:
- •A) High clinical-risk, defined as;
- •i. Medication-treated diabetes mellitus, AND/OR
- •B) High angiographic-risk lesion(s), with at least one target lesion in each
- •target vessel planned for randomization meeting at least one of the following
- •i. Target lesion is the culprit lesion responsible for either:
- •NSTEMI, defined as a clinical syndrome consistent with an acute coronary
- •syndrome and a minimum troponin of 1 ng/dL (may or may not have returned to
- •normal), and >1 mm ST segment deviation and/or dynamic T wave changes at rest
- •within 7 days, OR
- •STEMI >24 hours from the onset of ischemic symptoms
- •ii. long or multiple lesions (defined as intended total stent length in any
- •single target vessel >=28 mm),
- •iii. bifurcation intended to be treated with 2 planned stents (i.e. in both the
- •main branch and side branch), and where the planned side branch stent is >= 2.5
- •mm in diameter.
- •iv. angiographic severe calcification (defined as angiographically visible
- •calcification on both sides of the vessel wall in the absence of cardiac
- •v. chronic total occlusion (CTO) (enrolment and randomization in this case
- •performed only after successful antegrade wire escalation crossing and
- •pre-dilatation)
- •vi. in-stent restenosis (all patterns, as long as the lesion is at or within
- •the stent margin(s) and has an angiographically visually-assessed DS >=70% or DS
- •>=50% with non-invasive or invasive evidence of ischemia)
- •4. All target lesions (those lesions to be randomized) must have a visually
- •estimated or quantitatively assessed %DS of either >=70%, or >=50% plus one or
- •more of the following: an abnormal functional test (e.g. fractional flow
- •reserve, stress test) signifying ischemia in the distribution of the target
- •lesion(s) or biomarker positive ACS with plaque disruption or thrombus.
- •5. All target lesions must be planned for treatment with only >=2.5 mm and <=3.5
- •mm stents and post-dilatation balloons based on pre-PCI angiographic visual
- •estimation. The only exception is for long target lesions (visually estimated
- •as >20 mm), in which after implantation of a <=3.5 mm stent up to half of the
- •stented segment may be post-dilated with balloons >3.5 mm as needed per
- •operator judgment.
- •6. No more than 2 target lesions requiring PCI are present in any single
- •vessel., and no more than 2 target vessels are allowed. Thus, up to 4
- •randomized target lesions per patient in a maximum of 2 target vessels are
- •allowed, including branches. The intended target lesions will be declared just
- •prior to randomization.
- •7. All target lesions intended to be treated by PCI in the target vessel are
- •amenable to OCT-guided PCI.
- •8. For a female subject of childbearing potential, a pregnancy test must be
- •performed with negative results known within 7 days prior to the index
- •procedure per site standard, and pregnancy must not be intended for at least 2
- 另有 1 项未显示
排除标准
- •Clinical Criteria for exclusion:
- •1. STEMI <=24 hours from the onset of ischemic symptoms.
- •2. Creatinine clearance <=30 ml/min/1.73 m2 (as calculated by MDRD formula for
- •estimated GFR)5 and not on dialysis. Note: chronic dialysis dependent patients
- •are eligible for enrolment regardless of creatinine clearance.
- •3. Hypotension, shock or need for mechanical support or intravenous vasopressors
- •4. CHF (Killip class >=2 or NYHA class >=3)
- •5. LVEF <=30% by the most recent imaging test within 30 days prior to procedure
- •(echo, MRI, contrast left ventriculography or other)
- •6. Unstable ventricular arrhythmias
- •7. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12
- •months in the patient presenting with an ACS, or at least 6 months in the
- •patient presenting with stable CAD, unless the patient is also taking chronic
- •oral anticoagulation in which case a shorter duration of DAPT may be prescribed
- •per local standard of care.
- •8. Planned cardiac or non-cardiac surgery within 24 months after the index
- •9. Prior PCI within the target vessel within 12 months (unless the target
- •lesion is the prior PCI site - i.e. in-stent restenosis)
- •10. Any planned PCI within the target vessel(s) within 24 months after the
- •study procedure, other than a planned staged intervention in a second
- •randomized target vessel.
- •11. Any prior PCI in a non-target vessel within 24 hours before the study
- •procedure, or within previous 30 days if unsuccessful or complicated.
- •12. Subject has known hypersensitivity or contraindication to any of the study
- •drugs (including heparin and all P2Y12 inhibitors, one or more components of
- •the study devices, including everolimus, cobalt, chromium, nickel, platinum,
- •tungsten, acrylic and fluoropolymers, or radiocontrast dye that cannot be
- •adequately pre-medicated.
- •13. Subject has received any solid organ transplants or is on a waiting list
- •for any solid organ transplants.
- •14. Subject is receiving immunosuppressant therapy or has known
- •immunosuppressive or severe autoimmune disease that requires chronic
- •immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus
- •erythematosus, etc.). Note: corticosteroids are not included as
- •immunosuppressant therapy.
- •15. Subject has previously received or is scheduled to receive radiotherapy to
- •a coronary artery (vascular brachytherapy), or the chest/mediastinum.
- •16. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
- •17. Subject has a documented or suspected hepatic disorder as defined as
- •cirrhosis or Child-Pugh >= Class B.
- •18. Subject has a history of bleeding diathesis or coagulopathy, or has had a
- •significant gastro-intestinal or significant urinary bleed within the past six
- •19. Subject has had a cerebrovascular accident or transient ischemic
- •neurological attack (TIA) within the past six months, or any prior intracranial
- •bleed, or any permanent neurologic defect, or any known intracranial pathology
- •(e.g., aneurysm, arteriovenous malformation, etc.).
- •20. Subject has extensive peripheral vascular disease that precludes safe 6
- •French sheath insertion. Note: femoral arterial disease does not exclude the
- •patient if radial access may be used.
- •21. Subject has life expectancy <2 years for any non-cardiac cause.
- 另有 1 项未显示
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