NL-OMON43455已完成不适用
Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteries - Shockwave heart study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
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 > 18 years of age
- •2. Troponin must be less than or equal to the upper limit of lab normal value within 12 hours prior to the procedure
- •3. The target vessel must have a TIMI flow 3 at baseline
- •4. Patients with significant (> 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
- •5. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life
- •6. Single lesion stenosis of protected LMCA, LAD, RCA or LCX artery *50% in a reference vessel of 2.5 mm - 4.0 mm diameter and * 32 mm length
- •7. Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
- •8. Planned treatment of single lesions per vessel
- •9. Ability to pass a 0.014* guide wire across the lesion
- •10. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
- •11. Patient is able and willing to comply with all assessments in the study
排除标准
- •1. Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
- •2. Prior PCI procedure within the last 30 days of the index procedure
- •3. Patient has planned cardiovascular interventions within 30 days post index procedure
- •4. Second lesion with >50% stenosis in the same target vessel
- •5. Left ventricular ejection fraction < 40%
- •6. Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
- •7. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
- •8. Severe renal failure with serum creatinine >2.5 mg/dL
- •9. Untreated pre-procedural hemoglobin <10 g/dL
- •10. Coagulopathy manifested by platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
- •11. Patients in cardiogenic shock
- •12. Acute myocardial infarction (MI) within the past one (1) month, and/or elevated Troponin-I or T (with concomitant elevation of CK) at the time of enrollment
- •13. History of a stroke or transient ischemic attack (TIA) within 3 months
- •14. NYHA class III or IV heart failure
- •15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
- •16. Patients with a life expectancy of less than 1 year
- •17. Target main branch vessel < 2.4 mm in diameter
- •18. Target main branch lesion > 32 mm in length
- •19. Chronic Total Occlusion (CTO)
- •20. Previous stent procedure within 5 mm of target lesion
- •21. Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment
- •22. Unprotected Left Main diameter stenosis * 50%
- •23. Visible thrombus (by angiography) at target lesion site
- •24. Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass
- •25. Patient has active systemic infection
- •26. Patient has connective tissue disease (e.g., Marfan*s syndrome)
- •27. Patient has a hypercoagulable disorder
- •CONFIDENTIAL * Do Not Duplicate without Permission from Shockwave Medical
- •Shockwave Study Protocol, TD 0257 Revision C Page 11 of 54
- •28. Uncontrolled insulin dependent diabetes
- •29. Patient has allergy to imaging contrast media for which they cannot be pre-medicated
- •30. Evidence of aneurysm in target vessel
- •31. Patient is pregnant or nursing
研究者
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