NCT06687590招募中不适用
POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 20
- 主要终点
- Performance Endpoint
研究概览
简要总结
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.
The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.
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
- •Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.
- •Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.
- •Age of subject is >
- •Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.
排除标准
- •Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.
- •Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
结局指标
主要结局
Performance Endpoint
时间窗: Peri-procedural
Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a post- Serranator® residual stenosis of ≤30% by angiographic core laboratory assessment at the intended target lesion.
次要结局
- Safety Endpoint(Peri-procedural)
研究者
研究点 (20)
Loading locations...
相似试验
撤回
不适用
Serranator® Alto Post Market Clinical Follow Up (PMCF) StudyArterio-venous FistulaArteriovenous GraftPeripheral Arterial DiseaseNCT03538392Cagent Vascular LLC
已完成
不适用
External Ventricular Drainage Post-Market Clinical Follow-up RegistryDisorder CerebrospinalNCT05652296Integra LifeSciences Corporation120
已完成
不适用
MANTA Registry for Vascular Large-bore ClosureFemoral Arteriotomy ClosureNCT03330002Essential Medical, Inc.500
终止
不适用
Heart Lung Machine RegistryCardiac SurgeryThoracic SurgeryVascular SurgeryCardiopulmonary BypassNCT06159517Maquet Cardiopulmonary GmbH184
进行中（未招募）
不适用
MDR - Biomet Cannulated ScrewsFractures, BoneFracture MultipleNCT04002518Zimmer Biomet51