APERTO CVS PMCF Study: Drug Coated High Pressure Balloon in Large Veins (re)Stenosis in Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Clinically Assessed Intervention free period at 6 months fup
研究概览
简要总结
Prospective Observational Single Arm study aimed to assess safety and effectiveness of APERTO OTW DCB in treating stenosis and restenosis of central veins in dialysis patients
详细描述
The APERTO CVS PMCF study is aimed to evaluate safety and effectiveness of treatment of central veins (re)stenosis in dialysis patients at short and mid-term follow up, after treatment with APERTO OTW DCB. Primary endpoint will consist in evaluating the intervention free period for patients treated with APERTO OTW.
APERTO CVS PMCF Study will also collect data for post-market clinical follow up (PMCF) in a CE mark device used according to intended use
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients age >18, no pregnant women, able to perform fup visits, life expectancy > 12 months
- •Dialysis patients undergoing endovascular angioplasty due to clinically symptomatic stenosis (de novo or restenosis) of the central veins with significant (>50%) stenosis and diameter
- •The target lesion consists of one or more lesions with a target lesion length of less than or equal to 100 mm
- •The target blood vessel diameter of the target lesion is between 6.0 and 16.0 mm (in angiographic or ultrasound evaluation);
- •If there are other non-target lesions, then non-target lesions must be successfully cured with a not drug coated balloon before treating the target lesion;
排除标准
- •Patients with CVS observed and estimated as nonsignificant (< 50% stenosis) or a vessel > 12 mm in diameter by visual estimation;
- •the patient is now participating in another clinical trial to evaluate drug or medical device;
- •patient enrolled for this trial before;
- •prenatal pregnancy test result for women of childbearing potential is non-negative, Lactating woman;
- •patients, who underwent major surgical procedures (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study;
- •patients scheduled to undergo major surgery (eg, thoracotomy, craniotomy, etc.) within 30 days after enrolment;
- •central veins lesions have been already treated with DCB before
- •presence of a bare metal stent (BMS) or stent graft or vascular access thrombosis in central veins
- •patients allergic or intolerant to paclitaxel, or contrast media;
- •patients whose life expectancy is less than 1 year
- •presence of Thrombus in central veins
- •tumor compression
- •thoracic inlet syndrome
- •patients implanted with pacing or cardioverter devices with leads
- •any other central line within the target lesion
- •Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device
结局指标
主要结局
Clinically Assessed Intervention free period at 6 months fup
时间窗: 6 months
clinically assessed intervention free period at 6 months (IFP) defined as dialysis access circuit with no need for clinically driven target lesion repeat intervention for symptom recurrence
次要结局
- Recirculation Rate(6 months)
- Procedural Technical Success(intraoperative)
- Procedural Clinical Success(intraoperative)
- Fistula Flow(6 months)
- Procedural Surgical Success(intraoperative)
- Major Adverse Event(12 months follow up)