NL-OMON51096招募中不适用
PRospective Evaluation of complete revascularization in patients with multiveSsel disease Excluding chroNic Total occlusions - PRESENT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
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. Age >= 18 years, <=85 years
- •2. The patient is an acceptable candidate for treatment with a drug eluting
- •stent in accordance with the applicable guidelines on percutaneous coronary
- •interventions, manufacturer*s Instructions for Use and the Declaration of
- •3. Patient indication, lesion length and vessel diameter of the target
- •lesion(s) are according to the *Instructions for Use* that comes with every
- •Resolute Onyx (Zotarolimus-Eluting stent) system.
- •4. The patient is willing and able to cooperate with study procedures and
- •required follow up visits
- •5. The subject or legal representative has been informed of the nature of the
- •study and agrees to its provisions and has provided an EC approved written
- •informed consent, including data privacy authorization
排除标准
- •1. Age <18 years and > 85 years.
- •2. Single coronary vessel disease.
- •3. No left anterior descending lesion.
- •4. Patients in cardiogenic shock.
- •5. Patients with STEMI.
- •6. Presence of a chronic total occlusion (CTO) defined as coronary lesion with
- •Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 on initial
- •angiography present for more than or equal to 3 months.
- •7. Left main coronary artery disease
- •8. Patients who cannot give informed consent or have a life expectancy of less
- •than 12 months.
- •9. Absolute contraindications or allergy that cannot be pre-medicated, to
- •iodinated contrast or to any of the study medications, including both aspirin
- •and P2Y12 inhibitors.
- •10. Patients with an extreme LAD tortuosity imparing OCT catheter advancement
- •11. Enrollment in another study with another investigational device or drug
- •trial that has not reached the primary endpoint . The patient may only be
- •enrolled once in the PRESENT study.
- •12. Previous coronary artery bypass grafting (CABG).
- •13. Patient requiring additional cardiac surgery within 6 months.
- •14. Women of childbearing potential who do not have a negative pregnancy test
- •result within 7 days before the procedure, women who are known to be pregnant,
- •or who are breastfeeding.
研究者
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