ACTRN12623000436673招募中Unknown
Prospective, Multicenter, Single-Arm, Feasibility Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave Mini C Flex Coronary IVL Catheter in individuals undergoing Non-Emergent PCI.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •General Inclusion Criteria
- •1. Subject is greater than or equal to 18 years of age
- •2. Subject is able and willing to comply with all assessments in the study.
- •3. Subjects with native coronary artery disease including stable or unstable angina or silent ischemia associated with the target coronary artery that are suitable for non-emergent PCI
- •4. Biomarkers (troponin) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure.
- •5. Left ventricular ejection fraction greater than 25%
- •6. Subject signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
- •7. Estimated life expectancy greater than 1 year.
- •Angiographic Inclusion Criteria
- •8. The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any interventional procedure
- •9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with stenosis greater than or equal to 70%
- •10. The target vessel reference diameter must be greater than or equal to 2.5 mm and less than or equal to 4.0 mm
- •11. The lesion length must not exceed 40 mm
- •12. The target lesion must meet one of the following criteria:
- •a) Evidence of moderate or severe calcification at the lesion site and with TIMI flow 0 or 1 at baseline. Moderate calcification defined as angiography with densities noted only during the cardiac cycle prior to contrast injection; severe calcification defined as: angiography with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall), OR
- •b) Documented evidence of a prior device un-crossable lesion (>3 days prior to the index procedure)
- •13. Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior to insertion of Mini C catheter (antegrade wire technique only)
排除标准
- •General Exclusion Criteria
- •1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
- •2. Subject is participating in another research study involving an investigational agent including pharmaceutical, biologic, or medical device that has not reached the primary endpoint
- •3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
- •4. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines
- •5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
- •6. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as clinical symptoms consistent with an acute coronary syndrome with troponin greater than 1 times the local laboratory’s upper limit of normal
- •7. Subject has acute or chronic renal disease with eGFR less than 30 ml/min/1.73m2 (using CKD-EPI formula)
- •8. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit
- •9. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months
- •10. Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
- •11. Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) greater than 1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
- •12. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count greater than 750,000 or other disorders
- •13. Uncontrolled diabetes defined as a HbA1c ?greater than or equal to 10%
- •14. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
- •15. Subjects with clinical evidence of cardiogenic shock
- •16. Uncontrolled severe hypertension (systolic BP greater than 180 mm Hg or diastolic BP greater than 110 mm Hg)
- •17. Subjects with a life expectancy of less than 1 year
- •18. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure
- •19. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure
- •20. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
- •21. Planned use of atherectomy, scoring or cutting balloon, sub-intimal reentry device, or any investigational device other than coronary IVL
- •Angiographic Exclusion Criteria
- •22. Evidence of moderate or severe calcification at the lesion site and with TIMI flow 2 to3 at baseline
- •23. Target vessel is excessively tortuous defined as the presence of two or more bends greater than 90º or three or more bends greater than 75º
- •24. Evidence of a serious angiographic complication in the target vessel prior to treatment with coronary IVL (severe dissection (Type D to F), perforation, abrupt closure, persistent slow-flow or persistent no reflow)
- •25. Definite or possible thrombus by angiography in the target vessel
- •26. Evidence of aneurysm in target vessel within 10 mm of the target lesion
- •27. Second lesion with greater than 50% stenosis in the same target vessel as the target lesion including its s
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