NL-OMON38569尚未招募3 期
Evaluation with OFDI of strut coverage of Terumo new Drug Eluting Stent TCD-10023 with biodegradable polymer at 1, 2 and 3 months. - DISCOVERY 1-TO-3 STUDY
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Terumo
- 入组人数
- 36
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 is at least 18 years old;
- •2. Patients is a suitable candidate for PCI;
- •3. Patient has multi-vessel disease with >=2 de-novo lesions in native coronary arteries suitable for treatment with TCD-10023 DES;
- •4. Target lesions are suitable for OFDI examination;
- •5. Patient requires staged procedure between 3-5 weeks after baseline procedure, according to investigator*s judgement;
- •6. Target vessel reference diameter is between 2.5 - 4.0 mm (visual assessment);
- •7. Patient has provided written informed consent;
- •8. Patient is affiliated to social security or equivalent system (France only).
排除标准
- •1. Patient has known allergy to sirolimus, cobalt, chromium, nickel, or contrast agent (that cannot be adequately premedicated);
- •2. Patient is not a suitable candidate for use of DAPT because of active or recent bleedings or for use of vitamin K antagonist, like warfarin, dabigatran, rivaroxaban or acenocoumarol;
- •3. Patient is presenting with STEMI at baseline procedure;
- •4. Patient has Killip class > 1 at admission;
- •5. Patient is in cardiogenic shock;
- •6. Patient is a female of childbearing potential;
- •7. Patient has life expectancy of less then 1 year;
- •8. Patient is expected to undergo major surgery within 3 months;
- •9. Patient has Left Main disease >= 50%;
- •10. Target lesion at bifurcation requiring 2 stents technique;
- •11. Target lesions are severely calcified;
- •12. Target lesion is aorta-ostially located (within 3 mm of vessel origin);
- •13. Patient has renal failure defined as estimated Glomerular Filtration Rate (eGFR) <50 mL/min/1.73m²;
- •14. Target lesions require preparation other than balloon pre-dilatation;
- •15. Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
- •Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials;
- •16. In the Investigator*s opinion patient has (a) co-morbid condition(s) that could limit the patient*s ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study;
- •17. Patient is under judicial protection (France only).
研究者
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