NCT06193954招募中不适用
Evaluation of a Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions in Patients With Chronic Angina Refractory to Maximally Tolerated Guideline Directed Medical Therapy
VasoStar, LLC4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年6月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Incidence of Treatment-Emergent Serious Adverse Events
研究概览
简要总结
The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
详细描述
This Early Feasibility Study (EFS) is proposed to evaluate the initial safety and efficacy of the VasoStar guidewire system to cross complex coronary vascular lesions in non-tortuous arterial segments which are resistant to crossing with a traditional interventional guidewire.
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
- •Male or female, over 18 years of age, presenting with at least one ischemia inducing lesion in a native coronary artery that is refractory to standard guidewire crossing. Chronic total occlusion (CTO) is defined as 100% coronary blockage for over a 3-month duration documented either by prior catheterization or by clinical evaluation
- •Suitable candidate for non-emergent, coronary angioplasty
- •Documented de-novo or restenotic coronary chronic total occlusion defined as a lesion with TIMI 0 flow for at least 90 days refractory to conventional guidewire crossing
- •Left ventricle ejection fraction > 20% within the last 12 months.
- •For antegrade chronic total occlusion procedures, activated clotting time (ACT) should be > 300 sec
- •Chronic total occlusion in a non-tortuous arterial segment
- •Voluntarily sign a Patient Informed Consent Form specific to the study.
- •Physically and mentally willing to comply with all study requirements.
排除标准
- •Successful target lesion crossing with a conventional wire system prior to enrollment
- •Prisoners.
- •Pregnancy
- •Patient has an active implantable.
- •Extensive dissection created by refractory guidewire
- •Severe ongoing congestive heart failure (New York Heart Association Class IV symptoms)
- •Active infection
- •Uncontrolled Hypertension (Systolic blood pressure > 180 mm) at the time of the procedure
- •History of severe reaction to contrast media
- •Recent myocardial infarction (within 2 weeks)
- •In-stent target lesion
- •Severe cerebrovascular disease including history of prior stroke or transient ischemic attack within 1 month at the time of the procedure
- •Saphenous vein graft (SVG) chronic total occlusion or an in-stent chronic total occlusion
- •Short life expectancy due to other illnesses such as cancer or pulmonary, hepatic or renal disease
- •Participation in another investigational protocol at the time of the procedure
结局指标
主要结局
Incidence of Treatment-Emergent Serious Adverse Events
时间窗: 30 days
Number of device- or procedure- related serious adverse events
Number of participants with successful crossing of the target lesion with the VasoStar guidewire system
时间窗: 1 day
次要结局
- Improved 6-minute walk distance at 12 months following the VasoStar successful procedure(12 months)
- Improved 6-minute walk distance at 6 months following the VasoStar successful procedure(6 months)
- Improved score on the Seattle Angina Questionnaire at the 12-month visit compared to the score at baseline(12 months)
- Reduced number of hospitalizations for cardiac symptoms within 1 year following the VasoStar procedure, compared to the reported number of hospitalizations following standard CTO procedures.(1 year)
- Reduced number of emergency room visits for cardiac symptoms within 1 year following the VasoStar procedure, compared to the reported number of hospitalizations following standard CTO procedures.(1 year)
- Improved score on the Seattle Angina Questionnaire at the 6-month visit compared to the score at baseline(6 months)
研究者
研究点 (4)
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