NL-OMON51377招募中不适用
OPtimal stEnt deployment stRategy oF Contemporary sTents - PERFECT PSP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 247
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. Stable angina patients or acute coronary syndrome patients with bystander
- •stable coronary artery disease
- •2. With one or more significant epicardial stenosis in native coronary arteries
- •suitable for direct stenting, according to the judgement of treating operator.
- •The use of fractional flow reserve (FFR) or resting indices like iFR and RFR to
- •assess lesion severity is encouraged.
- •3. Subject must be at least 18 years of age
- •4. Written consent to participate in the study
排除标准
- •1. Lesions not suitable for direct stenting, like (sub)-total stenosis,
- •severely calcified lesions
- •2. Culprit lesions of acute coronary syndrome cannot be randomized to the
- •trial. After successful treatment of the ACS culprit lesion, patients however
- •can be randomized in the trial in case of remaining stable non-culprit lesions
- •that thought to be stented directly of during a staged procedure.
- •3. Lesions not suitable for OCT catheter delivery and imaging, e.g. left main
- •or ostial right coronary artery stenosis, lesions in coronary bypass grafts or
- •tortuous anatomy
- •4. Treatment for in-stent restenosis
- •5. Bifurcation lesions in which a two-stent technique or a proximal
- •postdilatation is planned.
- •6. Treatment of coronary artery bypass grafts
- •7. Creatine Clearance <= 30 ml/min/1.73 m2 (as calculated by MDRD formula for
- •estimated GFR)
- •8. Known hypersensitivity or allergy for cobalt chromium
- •9. Known comorbidity associated with a life expectancy < 1 year
- •10. Unable to understand and follow study-related instructions or unable to
- •comply with study protocol
- •11. Known comorbidity associated with a life expectancy < 1 year
研究者
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