Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA) - A Prospective Multi-centre Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Procedural Success Rate
研究概览
简要总结
Pre-market, single-arm, prospective, open-label, multi-center clinical trial aimed at assessing the safety and the performance of the Medyria TrackCath system in patients undergoing endovascular intervention.
详细描述
Pre-market, single-arm, prospective, open-label, multi-center clinical trial aimed at assessing the safety and the performance of the Medyria TrackCath system in patients above the age of 18 years who have been diagnosed with aneurysms in the thoracoabdominal (TAAA) or abdominal (AAA) aorta and require endovascular intervention.
The TrackCath System is a non-implantable disposable device, intended to measure real-time changes in the Blood Flow Velocity and to provide a pathway for delivering third-party guidewires and/or catheters.
Following patient consent, data is collected until discharge.
To reach 80% power, a total number of 32 patients (minimum 42 target orifices) is scheduled, including a minimum of 8 roll-in patients for the training phase, which comprises at least two successful cases per center.
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
- •Patient has signed and understood the approved Informed Consent form and is able to meet the proposed study proceedings (CIP).
- •Patient is ≥18 years of age
- •Need for standard or complex EVAR of AAA according to the relevant guidelines:
- •Asymptomatic aneurysms with a diameter > 55mm in men and > 50 mm in woman
- •Aneurysm-growth exceeds 10mm/year
- •Patient requires at least one cannulation during which requires at least one cannulation (e.g. fenestration of endograft, side-branch and/or contralateral leg of endograft)
排除标准
- •Patient is generally contraindicated for EVAR
- •Patient requires an emergency surgery
- •Patient with an increased risk of aneurysm rupture or saccular aneurysm, aneurysm with isolated wall protuberances or penetrating aortic ulcer
- •Patient with a dissecting acutely ruptured or leaking aneurysm or an acute vascular injury caused by a trauma
- •Patient with stroke or transient ischemic attack (TIA) within the last 6 months prior to baseline
- •Patient with myocardial infarction (MI) with the last 3 months prior to baseline
- •Patient with acute or chronic renal failure (including dialysis); Creatinine > 2.00 mg/dl or > 182 µmol/L
- •Patient with co-morbidities that constitutes an unacceptable risk (for example chronic obstructive pulmonary disease (COPD), liver failure, immunosuppression, polyneuropathy and hematological diseases)
- •Patient with bleeding history or coagulopathy
- •Patient with contraindication or allergies to take anticoagulants, antiplatelet drugs or contrast media
- •Life expectancy of less than 5 years
- •Female patient that is pregnant, is planning on becoming pregnant in the next month or is breastfeeding
- •Patient with inability to obtain vascular access
- •Patient has an active local or systemic infection
- •Patient is currently participating in another investigational study where the endpoints have not yet been achieved
- •Patient has a mental illness, and/or been diagnosed as clinically depressed or belongs to a vulnerable population (e.g., prisoner, severe drug abuser, developmentally disabled) that would compromise the ability to provide informed consent.
- •Patient has an obstructed or inadequate vasculature by means of tortuous anatomy hindering the TC catheter to reach target orifice(s)
- •Patient has an elevated risk of plaque dislodgment.
结局指标
主要结局
Procedural Success Rate
时间窗: Intra-operative
Successful TrackCath delivery of the distal end of the guidewire or of the 4 French catheter to the selected targeted orifice(s).
Primary Safety (All SADEs)
时间窗: Up to discharge (expected to be within 1 month)
Occurrence of Serious Adverse Device Effects (SADE)
次要结局
- Secondary Safety (All AEs)(Up to discharge (expected to be within 1 month))
- Procedural Parameters (contrast dye)(Intra-operative)
- Procedural Parameters (procedural times)(Intra-operative)
- Procedural Parameters (Blood flow velocity)(Intra-operative)
- Surgeon satisfaction rate(Intra-operative)