NL-OMON36492已完成2 期
PIONEER Trial, A Prospective, Multicentre, Single arm, Non-Inferiority Clinical Trial to evaluate safety of Drug Eluting PTCA Balloons and CoCr coronary Stents mounted on a Drug Eluting Balloon - PIONEER Trial
Blue Medical Devices BV0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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. Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia
- •2. Patients who are eligible for coronary revascularization (percutaneous angioplasty and/or CABG).
- •3. Patients with up to two de novo lesion in a native coronary artery >50% and <100% stenosis.
- •4. Reference diameter between 2.0mm and 4.0mm and maximum lesion length of 26mm
- •5. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.
排除标准
- •1. Patients under the age of 18 or unable to give informed consent.
- •2. Women who are pregnant. Women of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable contraception at a minimum until after the angiographic follow up.
- •3. Patients who previously participated in this study.
- •4. 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.
- •5. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.).
- •6. Patients treated with drug eluting stent(s) in the target vessel less than 12 months prior to the index procedure
- •7. Patients with a previous stent in the target lesion (in-stent Restenosis)
- •8. Patients with angiographic evidence of severe calcification of the target lesion.
- •9. Angiographic evidence of presence of thrombus in the target vessel
- •10. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
- •11. Patients with recent (<= 48 hours) myocardial infarction.
- •12. Patients with a contraindication to an emergent coronary bypass surgery.
- •13. Any individual who may refuse a blood transfusion.
- •14. Severe renal insufficiency (creatinine > 160 *mol/L or maximum flow declination rate (GFR < 50 ml/min).
- •15. Patients with intolerance or contraindication to the required medication (heparin, aspirin, clopidogrel and prasugrel, Paclitaxel).
- •16. Patients with contrast agent hypersensitivity that cannot be adequately pre-medicated.
研究者
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