跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT04151628
NCT04151628已完成不适用

Prospective, Multicenter, Single-Arm Study of the SWM-1234 in Calcified Coronary Arteries (Disrupt CAD IV Study - Japan)

Shockwave Medical, Inc.16 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年11月6日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
16
主要终点
Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure
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 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.

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. Approximately 72 subjects at 8 sites in Japan will be enrolled. 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

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

  • •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 prior to the index 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.
  • •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 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.
  • •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
  • •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) b≥leeding 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 ≥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 (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days prior to the index procedure
  • •Planned non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures 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
  • •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

Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure

时间窗: Within 30 days of index procedure

The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Intent To Treat (ITT) population.

Percentage of Subjects With Procedural Success

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

次要结局

  • Number of Participants With Device Crossing Success(At end of procedure, with a mean total procedure time of 62.5 minutes)
  • Number of Participants With Angiographic Success (Residual Stenosis <50%)(At end of procedure, with a mean total procedure time of 62.5 minutes)
  • 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)
  • Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 24 Months(within 24 months of index procedure)
  • Non-Procedural MI at 30 Days(within 30 days of index procedure)
  • Non-Procedural MI at 6 Months(within 6 months of index procedure)
  • Non-Procedural MI at 12 Months(within 12 months of index procedure)
  • Non-Procedural MI at 24 Months(within 24 months of index procedure)
  • Number of Participants With Angiographic Success (Residual Stenosis <=30%)(At end of procedure, with a mean total procedure time of 62.5 minutes)
  • Number of Participants With Serious Angiographic Complications(At end of procedure, with a mean total procedure time of 62.5 minutes)
  • MACE Rate at 6 Months(within 6 months of index procedure)
  • MACE Rate at 12 Months(within 12 months of index procedure)
  • MACE Rate at 24 Months(within 24 months of index procedure)
  • Target Lesion Failure (TLF) at 30 Days(Within 30 days of index procedure)
  • Target Lesion Failure (TLF) at 6 Months(Within 6 months of index procedure)
  • Target Lesion Failure (TLF) at 12 Months(Within 12 months of index procedure)
  • Target Lesion Failure (TLF) at 24 Months(Within 24 months of index procedure)
  • All-Cause Death at 12 Months(within 12 months of procedure)
  • All-Cause Death at 24 Months(within 24 months of procedure)
  • Myocardial Infarction (MI) at 30 Days(within 30 days of index procedure)
  • Myocardial Infarction (MI) at 6 Months(Within 6 months of index procedure)
  • Myocardial Infarction (MI) at 12 Months(Within 12 months of index procedure)
  • Myocardial Infarction (MI) at 24 Months(Within 24 months of index procedure)
  • Myocardial Infarction Attributable to Target Vessel (TV-MI) at 30 Days(within 30 days of index procedure)
  • Myocardial Infarction Attributable to Target Vessel (TV-MI) at 6 Months(Within 6 month of index procedure)
  • Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 30 Days(within 30 days of index procedure)
  • Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 6 Months(within 6 months of index procedure)
  • Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 12 Months(within 12 months of index procedure)
  • All-Cause Death at 30 Days(Within 30 days from index procedure)
  • Ischemia-driven Target Vessel Revascularization (ID-TVR) at 24 Months(within 24 months of index procedure)
  • Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 24 Months(within 24 months of index procedure)
  • Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 30 Days(within 30 days of index procedure)
  • Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 6 Months(within 6 months of index procedure)
  • Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 12 Months(within 12 months of index procedure)
  • Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 24 Months(within 24 months of index procedure)
  • Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 30 Days(within 30 days of index procedure)
  • Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 6 Months(within 6 months of index procedure)
  • Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 12 Months(within 12 months of index procedure)
  • Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 24 Months(within 24 months of index procedure)
  • Procedural MI at 30 Days(within 30 days of index procedure)
  • Procedural MI at 6 Months(within 6 months of index procedure)
  • All-Cause Death at 6 Months(within 6 months of index procedure)
  • Myocardial Infarction Attributable to Target Vessel (TV-MI) at 24 Months(Within 24 months of index procedure)
  • Procedural MI at 12 Months(within 12 months of index procedure)
  • Procedural MI at 24 Months(within 24 months of index procedure)
  • Myocardial Infarction Attributable to Target Vessel (TV-MI) at 12 Months(Within 12 months of index procedure)
  • Stent Thrombosis at 30 Days(Within 30 days of index procedure)
  • Stent Thrombosis at 6 Months(within 6 months of index procedure)
  • Stent Thrombosis at 12 Months(within 12 months of index procedure)
  • Stent Thrombosis at 24 Months(within 24 months of index procedure)
  • All Revascularizations at 30 Days(within 30 days of index procedure)
  • All Revascularizations at 6 Months(within 6 months of index procedure)
  • All Revascularizations at 12 Months(within 12 months of index procedure)
  • All Revascularizations at 24 Months(within 24 months of index procedure)
  • Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 30 Days(within 30 days of index procedure)
  • Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 6 Months(within 6 months of index procedure)
  • Ischemia-driven Target Vessel Revascularization (ID-TVR) at 12 Months(within 12 months of index procedure)
  • Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 30 Days(within 30 days of index procedure)
  • Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 6 Months(within 6 months of index procedure)
  • Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 12 Months(within 12 months of index procedure)
  • Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 24 Months(within 24 months of index procedure)
  • Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 30 Days(within 30 days of index procedure)
  • Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 6 Months(within 6 months of index procedure)
  • Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 12 Months(within 12 months of index procedure)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (16)

Loading locations...

相似试验

已完成
不适用
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)Peripheral Arterial DiseaseCritical Limb Ischemia
NCT05358353ReFlow Medical, Inc.130
终止
4 期
A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.Advanced Prostate Cancer
NCT03971110AstraZeneca9
终止
不适用
The Pristine Post-Market StudyHemodialysis ComplicationHemodialysis Catheter InfectionHemodialysis Access FailureCentral Venous Catheter Related Bloodstream InfectionEnd Stage Renal DiseaseKidney Failure, Chronic
NCT05228132C. R. Bard142
尚未招募
不适用
Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve PalsyBell's PalsyRamsay Hunt SyndromeLyme DiseaseFacial Palsy
NCT06542289Neurotrigger Ltd80
招募中
不适用
Etoposide+Cytarabine+PEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological MalignanciesLymphomaMultiple Myeloma
NCT05536154The Affiliated People's Hospital of Ningbo University68