NCT05232760已完成不适用
SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis
Klinikum Arnsberg1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年3月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of patients with primary patency of juxta-anastomose at month 3
研究概览
简要总结
The purpose of this exploratory study is to evaluate safety and effectiveness of treatment of juxta-anastomotic (re)stenosis with SUPERA stent by improving hemodynamic situation through obtuse shaping of the anastomosis.
详细描述
Up to 50 patients undergoing percutaneous intervention due to juxta-anastomotic (re-)stenosis of the AV fistulas will be enrolled in this single-arm, prospective, multi-center CE marked study (IIT). Hemodialysis patients with failing radial-cephalic arteriovenous fistula (AVF) will receive treatment with the SUPERA stent and will be followed-up at 1, 3, 6 and 12 months after the procedure.
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 must be ≥ 18 years of age, able to perform follow-up visits, have a life expectancy > 12 months.
- •Hemodialysis patients undergoing endovascular angioplasty due to a clinically symptomatic stenosis (de novo or restenosis) of the juxta-anastomotic radiocephalic AVF with significant stenosis (lumen diameter < 2.7mm)
- •Patients with at least one previous endovascular intervention to restore AVF function
- •The target lesion consists of one or more lesions with a target lesion length of less than or equal to 80 mm in the juxta-anastomotic segment of the radiocephalic AVF
- •The target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (in angiographic or ultrasound evaluation)
- •If there are other non-target lesions, then non-target lesions must be successfully cured with a balloon before treating the target lesion
排除标准
- •Patients with AVF stenosis observed and estimated as nonsignificant (lumen diameter > 2.7mm) or a vessel <4.0 and > 7.5 mm in diameter by visual estimation
- •Patients with a known hypersensitivity or contraindication to anticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannot be adequately pre-medicated.
- •Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.
- •Patients that are currently participating in another clinical trial involving any investigational drug or device that may potentially confound the results of the study, or that would limit the patient's compliance with the follow-up requirements of the study.
- •Prior enrolment in this trial
- •Women who are pregnant or lactating
- •Patients, who underwent a major surgery (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study.
- •Patients, who have scheduled a major surgery (such as thoracotomy, craniotomy, etc.). within 30 days after enrolment -
研究组 & 干预措施
SUPERA peripheral stent system
干预措施: Supera™ Peripheral Stent System (Device)
结局指标
主要结局
Number of patients with primary patency of juxta-anastomose at month 3
时间窗: 3 months
Primary patency is defined as clinically assessed intervention free (IFP) period
次要结局
- Number of patients with technical success(Day 1 after the index procedure)
- Number of patients with access circuit patency(1,3,6,12 months)
- Number of patients with primary patency of juxta-anastomose(1, 6 and 12 months.)
- Number of patients with assisted primary patency(1, 3, 6 and 12 months)
- Number of patients with secondary patency(1, 3, 6 and 12 months)
- Recirculation rate(1, 3, 6 and 12 months)
- Fistula flow(1, 3, 6 and 12 months)
- Number of patients with procedural success(1 day (discharge))
- Number of patients with clinical success(1 day (discharge))
- Incidence of major adverse events(6 and 12 months)
研究者
研究点 (1)
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