NCT05966662已完成不适用
Prospective, Multicenter, Single-Arm IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD Duo Study)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 28
- 主要终点
- Percentage of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure
研究概览
简要总结
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.
详细描述
The Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.
Up to 145 subjects (138 evaluable) subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) will be enrolled at up to 20 US sites.
Enrollment duration will be approximately 10-12 months and study duration will be approximately 2 years.
Each subject will be followed through discharge, 30 days, 6, and 12 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
- •Subjects are required to meet all of the following inclusion criteria in order to be enrolled in the clinical study.
- •General Inclusion Criteria
- •Subject is ≥18 years of age
- •Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
- •For subjects with unstable ischemic heart disease, biomarkers (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours prior to the procedure (note: both must be normal)
- •For subjects 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 (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours of the procedure (note: both must be normal)
- •If 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 criterion; 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
- •Non-target lesions 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
- •Subjects who meet any of the following exclusion criteria may not be enrolled in the study:
- •General Exclusion Criteria
- •Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
- •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 antiplatelet/anticoagulation therapy per society guidelines
- •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 greater than 1 times the local laboratory's upper limit of normal
- •New York Heart Association (NYHA) class III or IV heart failure
- •Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73m2 (using CKD-EPI formula)
- •History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit
- •Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 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 related blood disorders
- •Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
- •Subjects with clinical evidence of cardiogenic shock
- •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
- •Angiographic Exclusion Criteria
- •Unprotected left main diameter stenosis >30%
- •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 located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
- •Previous stent within 5 mm of the target lesion regardless of the timing of its implantation
- •Angiographic evidence of a dissection or perforation in the target vessel at baseline or after guidewire passage
研究组 & 干预措施
Single-Arm
Experimental
Subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI).
干预措施: IVL with Shockwave C2+ 2Hz Coronary IVL Catheter (Device)
结局指标
主要结局
Percentage 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
Freedom from MACE within 30 days of the index procedure. MACE is defined as a composite occurrence of: cardiac death, myocardial infarction (MI), target vessel revascularization (TVR) after the completion of the index procedure.
Percentage of Participants With Procedural Success (Residual Stenosis ≤30%)
时间窗: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
Procedural Success post stent delivery with a residual stenosis ≤30% (core laboratory assessed) and without in-hospital MACE.
次要结局
- Number of Participants With Serious Angiographic Complications(at end of procedure)
- Number of Participants With Angiographic Success (Residual Stenosis <50%)(at the end of procedure)
- All-Cause Death Rate at 30 Days(within 30 days of index procedure)
- Cardiac Death Rate at 30 Days(within 30 days of index procedure)
- MI Rate at 30 Days(within 30 days of index procedure)
- Procedural MI Rate at 30 Days(within 30 days of index procedure)
- Non-Procedural MI Rate at 30 Days(within 30 days of index procedure)
- Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days(within 30 days of index procedure)
- Non-ID-TLR Rate at 30 Days(within 30 days of index procedure)
- Any Revascularizations Rate at 30 Days(within 30 days of index procedure)
- Stent Thrombosis Rate at 30 Days(within 30 days of index procedure)
- Rate of MI Using the 4th Universal Definition at 30 Days(within 30 days of index procedure)
- Number of Participants With Device Crossing Success(at the end of procedure)
- Number of Participants With Procedural Success (Residual Stenosis <50% and Without In-hospital MACE)(at the end of the procedure)
- Number of Participants With Angiographic Success (Residual Stenosis ≤30%)(at end of procedure)
- Target Lesion Failure Rate at 30 Days(within 30 days of index procedure)
- Target Vessel-MI (TV-MI) Rate at 30 Days(within 30 days of index procedure)
- Ischemia Driven-Target Vessel Revascularization (ID-TVR) Rate at 30 Days(within 30 days of index procedure)
- Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) Rate at 30 Days(within 30 days of index procedure)
研究者
研究点 (28)
Loading locations...
相似试验
招募中
不适用
Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)Thoracoabdominal Aortic AneurysmAortic DissectionAbdominal Aortic AneurysmNCT04746677Beth Israel Deaconess Medical Center180
终止
不适用
A Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic StrokeStroke, AcuteNCT03957278MIVI Neuroscience, Inc.4
招募中
不适用
Safety and Effectiveness of the Yaari Extractor for Management of Shoulder DystociaShoulder DystociaNCT05913609FetalEase Ltd.80
招募中
不适用
FORWARD CAD IDE StudyCoronary Arterial Disease (CAD)NCT06662500Shockwave Medical, Inc.408
撤回
不适用
Resveratrol Excipient Paclitaxel Coated Balloon for Coronary TreatmentIn-stent Coronary Artery RestenosisCoronary Artery RestenosisIn-stent RestenosisNCT05093244B. Braun Medical Inc.