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临床试验/NCT03595176
NCT03595176已完成不适用

Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries

Shockwave Medical, Inc.95 个研究点 分布在 4 个国家目标入组 431 人开始时间: 2019年1月9日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
431
试验地点
95
主要终点
Number of Participants With Procedural Success (Residual Stenosis <50%)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

详细描述

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). Approximately 392 subjects at 50 sites will be enrolled. A minimum of 50% of the total enrollment will come from the United States.Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.

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

性别
All
接受健康志愿者
否

入选标准

  • •Subject is ≥18 years of age
  • •Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
  • •For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn, both must be normal).
  • •For patients with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.
  • •If drawn prior to the procedure, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours of the procedure (note: if both labs are drawn, both must be normal).
  • •If biomarkers are drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment (note: CK-MB is required if drawn from the sheath).
  • •Left ventricular ejection fraction >25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criteria; may be assessed at time of index procedure)
  • •Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
  • •Lesions in non-target vessels requiring PCI may be treated either:
  • •>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
  • •>24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation >normal; or
  • •>30 days after the study procedure
  • •Angiographic Inclusion Criteria
  • •The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  • •Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with:
  • •Stenosis of ≥70% and <100% or
  • •Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
  • •The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
  • •The lesion length must not exceed 40 mm
  • •The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre- dilatation)
  • •Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
  • •Ability to pass a 0.014" guide wire across the lesion

排除标准

  • •Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
  • •Subject is a member of a vulnerable population as defined in 21 CFR 56.111, including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention
  • •Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
  • •Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
  • •Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for patients not on oral anticoagulation)
  • •Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
  • •Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK-MB greater than 1 times the local laboratory's upper limit of normal
  • •New York Heart Association (NYHA) class III or IV heart failure
  • •Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
  • •History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
  • •Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
  • •Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
  • •Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) > 1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
  • •Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders
  • •Uncontrolled diabetes defined as a HbA1c greater than or equal to 10%
  • •Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
  • •Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
  • •Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
  • •Subjects with a life expectancy of less than 1 year
  • •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
  • •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
  • •Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
  • •Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
  • •High SYNTAX Score (≥33) if assessed as standard of care, unless the local heart team has met and recommends PCI is the most appropriate treatment for the patient
  • •Unprotected left main diameter stenosis >30%
  • •Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º
  • •Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
  • •Evidence of aneurysm in target vessel within 10 mm of the target lesion
  • •Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion
  • •Target lesion is a bifurcation with ostial diameter stenosis ≥30%
  • •Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
  • •Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  • •Previous stent within the target vessel implanted within the last year
  • •Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
  • •Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

结局指标

主要结局

Number of Participants With Procedural Success (Residual Stenosis <50%)

时间窗: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis \<50% (core laboratory assessed) and without in-hospital MACE. The primary endpoints were analyzed using the Pivotal Analysis Set.

Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure

时间窗: within 30 days of index procedure

The primary safety endpoint was freedom from MACE at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.

次要结局

  • Cardiac Death Rate at 30 Days(within 30 days of index procedure)
  • Number of Participants With Device Crossing Success(at end of procedure)
  • Target Lesion Failure (TLF) Rate at 6 Months(within 6 months of index procedure)
  • Number of Participants With Angiographic Success (Residual Stenosis <50%)(at end of procedure)
  • Number of Participants With Angiographic Success (Residual Stenosis <=30%)(at end of procedure)
  • Number of Participants With Serious Angiographic Complications(at end of procedure)
  • MACE Rate at 12 Months(within 12 months of index procedure)
  • Cardiac Death Rate at 24 Months(within 24 months of index procedure)
  • Number of Participants With Procedural Success (Residual Stenosis <=30%)(12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure)
  • Target Lesion Failure (TLF) Rate at 30 Days(within 30 days of index procedure)
  • All-Cause Death Rate at 6 Months(within 6 months of index procedure)
  • All-Cause Death Rate at 24 Months(within 24 months of index procedure)
  • MACE Rate at 6 Months(within 6 months of index procedure)
  • MACE Rate at 24 Months(within 24 months of index procedure)
  • Target Lesion Failure (TLF) Rate at 24 Months(within 24 months of index procedure)
  • MI Rate at 6 Months(within 6 months of index procedure)
  • TV-MI Rate at 12 Months(within 12 months of index procedure)
  • TV-MI Rate at 24 Months(within 24 months of index procedure)
  • Procedural MI Rate at 30 Days(within 30 days of index procedure)
  • Procedural MI Rate at 6 Months(within 6 months of index procedure)
  • Target Lesion Failure (TLF) Rate at 12 Months(within 12 months of index procedure)
  • All-Cause Death Rate at 30 Days(within 30 days of index procedure)
  • All-Cause Death Rate at 12 Months(within 12 months of index procedure)
  • Cardiac Death Rate at 6 Months(within 6 months of index procedure)
  • MI Rate at 24 Months(within 24 months of index procedure)
  • Non-Procedural MI Rate at 12 Months(within 12 months of index procedure)
  • ID-TVR Rate at 6 Months(within 6 months of index procedure)
  • Non-ID-TVR Rate at 6 Months(within 6 months of index procedure)
  • Non-ID-TVR Rate at 12 Months(within 12 months of index procedure)
  • Any Revascularizations Rate at 12 Months(within 12 months of index procedure)
  • Cardiac Death Rate at 12 Months(within 12 months of index procedure)
  • Procedural MI Rate at 12 Months(within 12 months of index procedure)
  • Procedural MI Rate at 24 Months(within 24 months of index procedure)
  • Ischemia-Driven Target Vessel Revascularization (ID-TVR) Rate at 30 Days(within 30 days of index procedure)
  • ID-TLR Rate at 6 Months(within 6 months of index procedure)
  • ID-TVR Rate at 12 Months(within 12 months of index procedure)
  • Any Revascularizations Rate at 24 Months(within 24 months of index procedure)
  • Stent Thrombosis Rate at 30 Days(within 30 days of index procedure)
  • Rate of MI Using the 4th Universal Definition at 24 Months(within 24 months of index procedure)
  • Rate of MI Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition at 30 Days(within 30 days of index procedure)
  • MI Rate at 30 Days(within 30 days of index procedure)
  • Non-Procedural MI Rate at 6 Months(within 6 months of index procedure)
  • ID-TVR Rate at 24 Months(within 24 months of index procedure)
  • Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days(within 30 days of index procedure)
  • ID-TLR Rate at 12 Months(within 12 months of index procedure)
  • Non-ID-TLR Rate at 24 Months(within 24 months of index procedure)
  • Any Revascularizations Rate at 30 Days(within 30 days of index procedure)
  • MI Rate at 12 Months(within 12 months of index procedure)
  • Target Vessel-Myocardial Infarction (TV-MI) Rate at 30 Days(within 30 days of index procedure)
  • TV-MI Rate at 6 Months(within 6 months of index procedure)
  • Non-Procedural MI Rate at 30 Days(within 30 days of index procedure)
  • Non-ID-TVR Rate at 30 Days(within 30 days of index procedure)
  • Non-ID-TVR Rate at 24 Months(within 24 months of index procedure)
  • Non-Procedural MI Rate at 24 Months(within 24 months of index procedure)
  • ID-TLR Rate at 24 Months(within 24 months of index procedure)
  • Any Revascularizations Rate at 6 Months(within 6 months of index procedure)
  • Stent Thrombosis Rate at 24 Months(within 24 months of index procedure)
  • Rate of MI Using the SCAI Definition at 6 Months(within 6 months of index procedure)
  • Non-ID-TLR Rate at 30 Days(within 30 days of index procedure)
  • Non-ID-TLR Rate at 6 Months(within 6 months of index procedure)
  • Non-ID-TLR Rate at 12 Months(within 12 months of index procedure)
  • Stent Thrombosis Rate at 12 Months(within 12 months of index procedure)
  • Stent Thrombosis Rate at 6 Months(within 6 months of index procedure)
  • Rate of MI Using the 4th Universal Definition at 30 Days(within 30 days of index procedure)
  • Rate of MI Using the 4th Universal Definition at 12 Months(within 12 months of index procedure)
  • Rate of MI Using the 4th Universal Definition at 6 Months(within 6 months of index procedure)
  • Rate of MI Using the SCAI Definition at 12 Months(within 12 months of index procedure)
  • Rate of MI Using the SCAI Definition at 24 Months(within 24 months of index procedure)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (95)

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