JPRN-jRCTs042180022已完成4 期
On-line 3-dimensional OPTical frequency domain IMaging to optimize bifurcation stenting using UltiMaster stent - OPTIMUM
Ozaki Yukio0 个研究点目标入组 110 人开始时间: 2018年12月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
研究概览
简要总结
In the randomized trial of bifurcation PCI, 3D-OFDI guidance was superior to angio-guidance in reducing acute incomplete stent strut apposition in the bifurcation segment (3D-OFDI 19.5+-15.8% vs. angio: 27.5%+-14.2%,p=0.008). Excellent feasibility of online 3D-OFDI was demonstrated (98%).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patient is at least 18 years of age and signed Informed Consent
- •2. Subject has coronary artery disease involving a bifurcation with objective evidence of ischemia including patients with chronic stable angina, silent ischemia and NSTE-ACS
- •3. Subject is appropriate to be treated by PCI according to the local practice (judgment of operator or heart team decision)
- •4. Patients residence is in the area covered by the hospital
- •5. Patients with angiographically significant stenosis (>50 % by visual assessment) in de novo, native, previously unstented bifurcation lesion(s) including left main lesion, which is in opinion of operator appropriate to be treated by PCI with a single stent strategy
- •6. The size of main vessel matches available Ultimaster stent sizes (2.25-4.0 mm in diameter by visual assessment).
- •7. The size of side branch is >2.0mm in diameter by visual assessment.
- •8. The sidebranch is treatable with a sidebranch fenestration and/or kissing balloon
排除标准
- •1. Pregnancy
- •2. Patients with ST elevation myocardial infarction
- •3. Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, sirolimus, contrast material
- •4. Known thrombocytopenia (platelet count< 100,000/mm3)
- •5. Cardiogenic Shock
- •6. Significant comorbidities precluding clinical follow-up (as judged by investigators)
- •7. Major planned surgery that requires discontinuation of dual antiplatelet therapy
- •8. History of stenting in the target bifurcation lesion
- •9. Renal insufficiency (GFR/MDRD <45 ml/min), which precludes in opinion of operator contrast injection during repeat OFDI pullback
- •10. Severely tortuous or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal optical frequency domain imaging (OFDI) or excessive risk of complication to place an OFDI catheter.
- •11. Target lesion reference vessel diameter (RVD) < 2.25 and > 4 mm
- •12. Others, Patient judged inappropriate by the attending physician
研究者
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