A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 17
- 主要终点
- Efficacy: Percentage of patients with device success
研究概览
简要总结
Biosensors, the Sponsor would like to determine if the Biosensors Microcatheter is safe and effective in treating patients with CTO by assessing a composite of in-hospital cardiac death or myocardial infarction and device success (defined as successfully facilitate placement of a guidewire beyond the occluded coronary segment), respectively.
详细描述
Prospective, multi-center, open-label single-arm trial designed to enroll 100 patients undergoing attempted CTO-PCI at up to 10 centers in the United Kingdom and N. Ireland. For assessment of efficacy, the ability of the BM to successfully facilitate placement of a guidewire beyond the occluded coronary segment will be assessed. Patients will be followed up until hospital discharge or 7 days post index procedure, whichever comes first. For the assessment of safety, the incidence of in-hospital cardiac death or myocardial infarction will be assessed at hospital discharge or 7 days post index procedure, whichever comes first.
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
- •Adult aged > 18 years
- •Patient understands and has signed the consent form.
- •Patient has an angiographically documented chronic total occlusion (i.e. estimated to be >3 months duration) showing distal TIMI 0 flow. Occlusion with absence of antegrade flow through the lesion and with a presumed or documented duration of 3 months.
- •Suitable candidate for non-emergent PCI
- •Left ventricle ejection fraction > 25%
排除标准
- •Patient unable to give informed consent.
- •Current participation in another study with any investigational drug or device.
- •Known or suspected contrast allergy.
- •in-stent CTO.
- •Planned treatment of a second CTO during the index procedure
- •Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel or Prasugrel or Ticagrelor).
- •Recent major cerebrovascular event (history of stroke or TIA within 1 month)
- •Renal insufficiency (serum creatinine of > 200μmol/L)
- •Active gastrointestinal bleeding
- •Active infection or fever that may be due to infection
- •Life expectancy < 2 years due to other illnesses
- •Significant anaemia (haemoglobin < 10.0g/L)
- •Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure)
- •Severe electrolyte imbalance
- •Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV.
- •Unstable angina requiring emergent PCI or coronary artery bypass graft (CABG)
- •Recent myocardial infarction (MI) (within the past one week)
- •Unwillingness or inability to comply with any protocol requirements
- •Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- •Extensive prior dissection from a coronary guidewire use
- •Drug abuse or alcoholism.
- •Patients under custodial care.
- •Bleeding diathesis or coagulation disorder
- •Kawasaki's disease or other vasculitis
结局指标
主要结局
Efficacy: Percentage of patients with device success
时间窗: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Device success defined as successful placement of a guidewire in the vessel across the occluded coronary segment
Safety: Percentage of patients with composite of in-hospital cardiac death or myocardial infarction.
时间窗: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Composite of in-hospital cardiac death or myocardial infarction.
次要结局
- Percentage of patients with technical success(Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.)
- Percentage of patients with procedural success(Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.)
- Percentage of patients with crossing success(Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.)