NCT05755711进行中（未招募）不适用
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 399
- 试验地点
- 49
- 主要终点
- Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF)
研究概览
简要总结
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.
详细描述
Subject population: up to 400 female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care at up to 50 global sites in the US, UK and Europe. Subjects will have clinical follow-up prior to discharge from the index intervention and at 30 days, 1, 2 and 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject is a non-pregnant female ≥18 years of age
- •The subject meets indications for PCI and stent
- •The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion
- •The subject is willing to comply with protocol-specified follow-up evaluations
- •The subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
排除标准
- •Subjects with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
- •Subjects presenting with cardiogenic shock at the time of the index procedure
- •Serious angiographic complication in the target vessel prior to treatment with coronary IVL including-severe dissection (Type D to F), perforation, abrupt closure, persistent slow-flow or persistent no reflow
- •Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines
- •Subject is enrolled in any study of an investigational device or drug that may interfere with study results
研究组 & 干预措施
Female subjects referred for percutaneous coronary intervention
Female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.
干预措施: Shockwave Medical Coronary IVL System (Device)
结局指标
主要结局
Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF)
时间窗: within 30 days of index procedure
Target lesion failure (TLF) at 30 days defined as a composite of cardiac death, myocardial infarction (per SCAI definition for peri-procedural MI; per 4th Universal Definition for spontaneous MI beyond discharge) attributable to target vessel (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR).
Primary Effectiveness Endpoint: Procedural Success
时间窗: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Procedural Success defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions (core laboratory assessed) and without in-hospital TLF (CEC adjudicated).
次要结局
- Angiographic Success (≤30% Residual Stenosis)(12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure)
- Procedural Success(12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure)
- Angiographic Success (< 50% Residual Stenosis)(12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure)
- Serious Angiographic Complications(12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure)
- Target Lesion Failure (TLF)-1 Year(1 year post procedure)
- Target Lesion Failure (TLF)- 2 Year(2 years post procedure)
- Target Lesion Failure (TLF)- 3 Year(3 years post procedure)
- Major Adverse Cardiac Events (MACE)- 30 Days(within 30 days of index procedure)
- Major Adverse Cardiac Events (MACE)- 1 Year(1 year post procedure)
- Major Adverse Cardiac Events (MACE)- 2 Year(2 years post procedure)
- Major Adverse Cardiac Events (MACE)- 3 Year(3 years post procedure)
- All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- Discharge(12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure.)
- All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 30 Days(within 30 days of index procedure)
- All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 1 Year(1 year post procedure)
- All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 2 Year(2 years post procedure)
- All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 3 Year(3 years post procedure)
- MI (Myocardial Infarction)- Discharge(12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure)
- MI (Myocardial Infarction)- 30 Day(within 30 days of index procedure)
- MI (Myocardial Infarction)- 1 Year(1 year post procedure)
- MI (Myocardial Infarction)- 2 Year(2 years post procedure)
- MI (Myocardial Infarction)- 3 Year(3 years post procedure)
- Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 30 Days(From baseline to within 30 days of index procedure)
- Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 1 Year(From baseline to within 1 year of index procedure)
- Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 2 Years(From baseline to within 2 years of index procedure)
- Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 3 Years(From baseline to within 3 years of index procedure)
- Quality of Life Assessed by EQ-5D-5L- Baseline to 30 Days(From baseline to within 30 days of index procedure)
- Quality of Life Assessed by EQ-5D-5L- Baseline to 1 Year(From baseline to within 1 year of index procedure)
- Quality of Life Assessed by EQ-5D-5L- Baseline to 2 Year(From baseline to within 2 years of index procedure)
- Quality of Life Assessed by EQ-5D-5L- Baseline to 3 Year(From baseline to within 3 years of index procedure)
- Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 30 Day(From baseline to within 30 days of index procedure)
- Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 1 Year(From baseline to within 1 year of index procedure)
- Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 2 Year(From baseline to within 2 years of index procedure)
- Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 3 Year(From baseline to within 3 years of index procedure)
研究者
研究点 (49)
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