NCT07510438招募中不适用
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease - A First-in-Human (FIH) Study
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 3
研究概览
简要总结
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Subjects with native coronary artery disease
- •Left ventricular ejection fraction (LVEF) ≥ 35% within 6 months
- •The target lesion must be a single de novo coronary lesion
- •The target lesion stenosis of left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with Stenosis of ≥70% and <100% or Stenosis ≥50% and <70% with evidence of ischemia
- •Lesion length must not exceed 44 mm
排除标准
- •Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days prior to index procedure.
- •Subject has New York Heart Association (NYHA) class III or IV heart failure.
- •Subject has renal failure with serum creatinine >2.5 mg/dL, or chronic dialysis.
- •Subject has a previous stent in the target vessel implanted within last six months.
- •Unprotected LMCA diameter stenosis >30%.
- •Target lesion has a myocardial bridge.
- •Target vessel is excessively tortuous, defined as the presence of 2 or more bends >90 degrees or 3 or more bends >75 degrees.
- •Evidence of aneurysm in target vessel within 10 mm of the target lesion.
- •Target lesion in ostial location (LAD, RCA, LCX, or RI, within 5 mm of ostium) or in an unprotected LMCA.
- •Target lesion is a bifurcation with ostial diameter stenosis ≥30%.
- •Any previous stent within 10 mm of the target lesion.
研究组 & 干预措施
Pulse Intravascular Lithotripsy™ (Pulse IVL™)
Experimental
Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls
干预措施: Pulse Intravascular Lithotripsy (Pulse IVL) (Device)
研究者
研究点 (3)
Loading locations...
相似试验
招募中
不适用
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAFAtrial FibrillationNCT07428564Biosense Webster, Inc.50
尚未招募
不适用
Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.Prostatic HyperplasiaUrinary RetentionUrinary CatheterizationIntermittent Urethral CatheterizationUrinary Tract InfectionsSurgical ProceduresNCT07555964University Hospital, Bordeaux106
尚未招募
1 期
Safety Evaluation of MSC-based Therapy for Liver Cihcrosis TreatmentLiver CirrhosisNCT07472270Vinmec Research Institute of Stem Cell and Gene Technology12
尚未招募
1 期
IASO206 in Patients With Relapsed/Refractory Multiple MyelomaNCT07322159Institute of Hematology & Blood Diseases Hospital, China12
尚未招募
不适用
Clinical Study on the Safety and Efficacy of CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological MalignanciesNCT07345780Donghua Zhang28