CTRI/2018/09/015656Other未知
Optical Coherence Tomography Evaluation on Struts Coverage and Vessel Wall Response: A Comparison of Tetrilimus Everolimus-eluting Stent Versus Xience Family of Everolimus-eluting Stents
Dr Deepak Davidson0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •General Inclusion Criteria:
- •1. Patient is >=18 years of age
- •2. Patient is eligible for percutaneous coronary intervention (PCI)
- •3. Patient has documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or documented silent ischemia or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C)
- •4. Patient demonstrates evidence of an ongoing acute myocardial infarction (eg. STEMI or enzyme elevation CKË?2X local laboratoryâ??s ULN unless CK-MB is <2X ULN)
- •5. Patient demonstrates a left ventricular ejection fraction (LVEF) of >=40% as measured prior to enrollment
- •6. Tetrilimus EES (alone) / Xience family of EES (alone) is/are to be implanted into the coronary vasculature during the index procedure
- •7. Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect
- •Angiographic Inclusion Criteria:
- •1. Up to 2 de novo lesions in separate coronary vessels with a visually estimated reference vessel diameter (RVD) >= 2.75 mm and <= 4.50 mm to be covered by same type of stent i.e., either Tetrilimus EES or Xience family of EES, in all lesions
- •2. Target lesion length must measure (by visual estimate) <= 40 mm
- •3. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >= 50% and <100%
排除标准
- •General Exclusion Criteria:
- •1. The patient has a life expectancy of less than 12 months due to another medical condition
- •2. Patient has a history of hypersensitivity to everolimus or structurally related compounds
- •3. Patient exhibits cardiogenic shock (systolic pressure <80 mm Hg and PCWP Ë?20 mm Hg or cardiac index <1.8 litres/minute/m² or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure Ë?80 mm Hg) for any time within 24 hours prior to index procedure
- •4. Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine Ë?2.0 mg/dl or 177 μmol/l)
- •5. Planned cardiac surgery procedure <=12 months post-index procedure
- •6. Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months
- •7. Patient demonstrates evidence of leukopenia (leukocyte count <3.5 X 10â?¹/litre)
- •8. Patient demonstrates evidence of thrombocytopenia (platelet count <100,000/mm³) or thrombocytosis (Ë?750,000/mm³)
- •9. Patient is contraindicated to Aspirin (successful prior desensitization to aspirin is not an exclusion), clopidogrel, or prasugrel or ticagrelor
- •10. Patient is currently on warfarin, or possibility of treatment with warfarin during the following 12 months post index procedure
- •11. Patient has been treated with everolimus or other chemotherapeutic agents within 12 months prior to planned index procedure
- •12. Known allergy to cobalt chromium (Co-Cr)
- •13. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure
- •14. Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation
- •Angiographic Exclusion Criteria:
- •1. Study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified, by visual estimate
- •2. Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a Ë?60 degree bend in the vessel
- •3. Study lesion involving bifurcation with a side branch larger than 2.0 mm in diameter
- •4. Arterial or saphenous vein graft lesions or lesions distal to a diseased arterial or saphenous vein graft
- •5. Previous treatment of the target lesion (excluding pre-dilation) with another interventional device
- •6. A target lesion with in-stent restenosis
研究者
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