Clinical Evaluation of the All'InCath Contrast Balloon Catheter 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Periprocedural Serious adverse events
研究概览
简要总结
The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
详细描述
The All'InCath Contrast Balloon Catheter 035M Balloon Dilatation Catheter has received 510(k) clearance for Percutaneous Transluminal Angioplasty in the peripheral vasculature, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, and angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media (K191275).
The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter, including device-related perioperative adverse events, vascular patency, visualization of the target area, duration of intervention, level of radiation exposure, dose of contrast agent, post-procedural adverse events and physician's feedback, 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
- •A participant will be eligible to participate in the study if all of the following apply:
- •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
- •Exclusion criteria
- •The following subjects will be excluded from the study if any of the following criteria are met:
- •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.
排除标准
- 未提供
结局指标
主要结局
Periprocedural Serious adverse events
时间窗: During procedure
Freedom from device related periprocedural adverse events and complications during PTA procedure (e.g., loss of guidewire, misdirection of catheter, vessel wall perforation or dissection requiring treatment).
Vascular patency
时间窗: immediately post-procedure
Vascular patency immediately post-procedure with adequate capability to ensure injection medium contrast into the vessel with a good visualization of the targeted area.
次要结局
- Duration of the intervention (PTA)(Time of the procedure)
- Level of radiation exposure during PTA (mGy).(During procedure)
- Dose of contrast agent injected at the targeted location (mL).(During procedure)
- Investigator's feedback(During procedure)
- Major adverse events during hospitalization until discharge(before hospital discharge or 24hours after the index-procedure which ever occurs first)