Clinical Evaluation of the All'InCath CBC 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of the All'InCath Contrast Balloon Catheter 035M
研究概览
简要总结
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities.
详细描述
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
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
- •Ability to provide Informed Consent
- •Can also be executed by the legal designated representative or the witness
- •As per the Principal Investigator's practices as per standard of care, the subject is indicated for PTA in the peripheral vasculature, including iliac, femoral, popliteal, and renal arteries, and any treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- •Male or female >18 years old.
- •Life expectancy >1 year
排除标准
- •Unstable coronary artery disease or any other uncontrolled comorbidity.
- •Myocardial infarction or stroke within two (2) months before baseline evaluation.
- •Previous peripheral bypass or procedure that includes the target vessel.
- •Known, untreated allergy or other contraindications to contrast agents or medications used during or after PTA.
- •Non-correctable bleeding diathesis, platelet dysfunction, thrombocytopenia, or any other known coagulopathy.
- •The use of antiplatelet or anticoagulant therapy is contraindicated.
- •Any planned major surgical or interventional procedure within 30 days after the study procedure.
- •Females who are breast-feeding or child-bearing potential and not using a medically reliable method of contraception (as defined below) for the entire study duration:
- •medically reliable contraception defined as: oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or those not using another method deemed by the Investigator to be sufficiently reliable.
- •subjects who are surgically sterilized / hysterectomized or post-menopausal for longer than two (2) years are not considered childbearing potential.
- •Positive pregnancy test result in women of child bearing potential or is breast-feeding.
- •Incapacitated individuals and those with psychiatric disorders that could interfere with the provision of informed consent, completion of tests, therapy, follow-up or general study compliance.
- •Participation in another study with investigational drug or device within the 30 days preceding and during the present study.
结局指标
主要结局
Safety of the All'InCath Contrast Balloon Catheter 035M
时间窗: immediately post-procedure
Periprocedural Serious Adverse Events
Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M
时间窗: immediately post-procedure
Vascular patency
次要结局
- Performance of the All'InCath Contrast Balloon Catheter 035M(Time of Procedure)
- Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M(During Procedure)
- Safety and performance of the All'InCath Contrast Balloon Catheter 035M(During Procedure)
- Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M(During Procedure)
- Safety of the All'InCath Contrast Balloon Catheter 035M(3 days)