A Single-Arm Study to Assess the Safety and Efficacy of the SoundBite™ Crossing System With ACTIVE Wire in Coronary Chronic Total Occlusions (the ACTIVE Trial).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 9
- 主要终点
- Device success
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of the SoundBite™ Crossing System - Coronary (SCS-C) in a subject population with chronic coronary artery disease including Chronic Total Occlusion (CTO).
详细描述
The study is intended to demonstrate that the SoundBite™ Crossing System - Coronary can facilitate the passage of either 1) devices intended to treat a CTO or 2) guidewires or additional crossing devices into the true lumen distal to the CTO.
SoundBite™ Crossing System - Coronary, which consists of a re-usable console and a disposable device (ACTIVE Wire).
The SoundBite™ Crossing System - Coronary is intended to facilitate passage of a guidewire or therapeutic devices through a coronary artery Chronic Total Occlusion.
This is a prospective, multi-center, multinational, single-arm, phased clinical study intended to provide pivotal data for device approval.
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
- •General inclusion Criteria
- •Subject planned to undergo clinically driven percutaneous coronary intervention (PCI) targeting a single CTO. Clinical justification of a CTO PCI includes anginal symptoms, dyspnea or left ventricular dysfunction presumed or documented to be the result of ischemia in the CTO territory.
- •PCI procedure is planned to be performed with a wire based antegrade primary strategy.
- •Subject is ≥ 18 years old.
- •Subject is able and willing to provide written informed consent prior to study procedure.
- •Angiographic Inclusion Criteria All angiographic inclusion criteria shall be documented at time of index procedure. Angiographic inclusion criteria are assessed at the site and determined by the site investigator.
- •Target CTO is in a native coronary artery and demonstrates TIMI flow grade
- •Target CTO is presumed documented angiographically to be greater than 3 months old.
- •Target CTO length is visually estimated to be ≥ 5mm.
- •Target reference vessel diameter ≥ 2.5mm.
- •Target CTO shows calcification.
- •Target CTO has a positive tap test, which correspond to the inability to penetrate the cap by visual estimate using a polymer-jacketed or enhanced tip stiffness (>1.5 gm) coronary guidewire manipulated with the intention to cross the occlusion for at least 60 seconds of fluoroscopy time after initial guidewire-cap contact. The tap test is intended to confirm the chronicity of the lesion and rule out acute or sub-acute occlusions that will likely be crossed with such simple wire maneuvers.
排除标准
- •Life expectancy < 1 year.
- •Hypersensitivity or contraindication to aspirin, P2Y12 platelet receptor inhibitors, heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available.
- •Target occlusion has an iatrogenic dissection that occurred within the past 3 months.
- •Subject has received ≥5 Gy exposure to the chest within 3 months.
- •Subject has known elevated cardiac biomarkers (CK-MB or cTn) within 30 days prior to index procedure.
- •Left ventricular ejection fraction less than 20%.
- •Severe aortic or mitral valve disease.
- •Planned left ventricular (LV) support device during CTO PCI.
- •History of bleeding diatheses, coagulopathy.
- •Recent (within 6 months prior to index procedure) stroke or transient ischemic attack (TIA).
- •Recent (within 6 months prior to index procedure) significant gastrointestinal (GI) bleeding.
- •Planned additional coronary or valvular percutaneous or surgical intervention scheduled within 30 days after index procedure.
- •Requires emergent or urgent PCI.
- •Positive pregnancy test result in women of child bearing potential or is breast-feeding.
- •Current participation in another investigational drug or device trial.
- •Other medical illnesses that may cause the subject to be non- compliant with the protocol or confound data interpretation.
- •Estimated Glomerular Filtration Rate (GFR) below 25 ml/min and not yet on dialysis.
- •Evidence of clinical instability (e.g., hemodynamic instability, sustained tachyarrhythmias, cardiogenic shock).
- •Angiographic Exclusion Criteria All angiographic inclusion criteria shall be documented at time of index procedure. Angiographic exclusion criteria are assessed at the site and determined by the site investigator.
- •Target CTO is in an unprotected left main.
- •No angiographically visible collateral flow to the target vessel distal to the occlusion, from ipsilateral or contralateral collaterals.
- •Vessel tortuosity proximal to, or within, body of target occlusion which, in the opinion of the investigator, is not amenable to advancement of a microcatheter or SoundBite™ Crossing System
结局指标
主要结局
Device success
时间窗: Day 1
Device Success defined as: Successful antegrade crossing of the CTO into the true arterial lumen distal to the occlusion following advancement of at least 3 mm of the Soundbite(TM) Crossing System into any segment as assessed by the core angiographic laboratory. An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (e.g. Stingray); absence of successful retrograde crossing of a collateral will still be considered an antegrade only approach.
Freedom from the composite SoundBite™ Crossing System related MAEs
时间窗: 48 hours or until discharge
Freedom from the composite SoundBite™ Crossing System related major adverse events (MAEs) at 48 hours or hospital discharge (whichever occurs first) post procedure, as per Clinical Events Committee (CEC) adjudication, defined as: * Cardiovascular related deaths * Myocardial Infarction (Primary definition of clinically relevant post procedure MI from SCAI (1). * Coronary Artery Perforation requiring treatment * Unscheduled cardiac surgery anytime between enrollment to completion of the study. * Intra-procedure stroke * Radiation exposure ≥ 8 Gy
次要结局
- Overall Device Success(Day 1)
- Procedural Success(Day 1)
- Freedom from SoundBite™ Crossing System related MAE(30 days post-procedure)
- Technical Success(Day 1)
- Clinical Success:(30 days post-procedure)