NL-OMON49521撤回2 期
DEBuT-LRP study: Non-invasive and Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques - DEBuT-LRP
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 40
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. Patient has an acute coronary syndrome without ST-segment elevation on the
- •ECG (NSTE-ACS), including non-ST-elevation myocardial infarction and unstable
- •angina pectoris.
- •2. An invasive revascularization strategy for NSTE-ACS with PCI is chosen.
- •3. The coronary arteries are open and patent on CTCA, thus feasible to scan all
- •major coronary arteries with IVUS/NIRS.
排除标准
- •Angiographic exclusion criteria:
- •1. Patient has additional lesions that cannot be treated during the index PCI
- •and need staged PCI;
- •2. A chronic total occlusion is present;
- •3. Previous coronary artery bypass-grafting;
- •4. Patient has a major procedural complication of the index PCI (coronary
- •perforation, coronary dissection);
- •Clinical exclusion criteria:
- •5. Irregular heart rhythm, affecting the CT quality (i.e. atrial fibrillation
- •or frequent premature ventricular contractions);
- •6. Technical aspects hampering appropriate CT assessment (i.e. the presence of
- •extreme calcifications or extreme tortuosity);
- •7. Unstable patients (the presence of cardiogenic shock, need for intubation,
- •need for inotropes);
- •8. Patients with ST-segment elevations on the ECG requiring immediate primary
- •9. Body weight > 250 kg;
- •10. Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] <30
- •mL/min/1.73m2 or subject on dialysis);
- •11. Hypersensitivity or allergy to contrast with inability to properly
- •pre-hydrate;
- •12. Presence of a comorbid condition with a life expectancy of less than one
- •13. Participation in another trial;
- •14. Subject is belonging to a vulnerable population (per investigator*s
- •judgment, e.g., subordinate hospital staff) or is unable to read or write.
研究者
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