Assessment of Clinical Capabilities of LIBERTY® Endovascular Robotic System's Performance and Safety in Peripheral Vascular Interventions: A Multi-Center, Single Arm, Prospective Trial (ACCESS-PVI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Effectiveness Endpoint
研究概览
简要总结
A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions. The study is designed to evaluate the performance and safety of endovascular procedures supported by the LIBERTY® Robotic System. The System is configured to deliver and manipulate third-party commercially available surgical devices that are employed in endovascular transcatheter procedures (guidewires, microcatheters, and guiding catheters).
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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is age 22-80 years at screening.
- •The subject has been informed of the nature of the study and is willing and able to provide informed consent to participate in the study.
- •The subject has a clinical indication for an elective PVI.
- •The subject is willing and able to comply with all required study procedures.
- •Subject's scheduled procedure is compatible with commercially available peripheral interventional devices that have the following diameter ranges:
- •Guidewires: 0.014-0.018"
- •Catheters (Microcatheters): 2-3 Fr
- •Guide catheter: 4-6 Fr
排除标准
- •Subject is planned to undergo coronary and/or neuro-interventional procedures during study procedure.
- •Subject with vasculature that cannot accommodate the catheter or required accessories according to local routine practice guidelines.
- •Subject with contraindication to endovascular approach to the treatment of peripheral vascular disease, similar or same as contraindications in manual procedures.
- •Target vessel has been previously treated with any type of a bypass conduit.
- •Subject has a contraindication to standard anticoagulation for PVIs.
- •Subject has bleeding or a hypercoagulability disorder.
- •Subject has thrombocytopenia (<50 x103 per µL).
- •Subject has abnormal, clinically relevant lab results resulting in treatment and/or increased risk to the subject.
- •Subject has an elevated serum creatinine (≥2.5 mg/dL or ≥221 mmol/L).
- •Subject has an active infection requiring antibiotic or anti-fungal systemic treatment.
- •Subject has a known allergy to any material used or any component of the devices used that will be in direct contact with subject's tissue.
- •Subject is pregnant or lactating.
- •Subject with any medical, social, or psychological conditions which, in the opinion of the investigator, would prohibit appropriate consent or impair completion of the study protocol or study procedures.
- •Subject who is incapable, per the investigator's discretion, of following-up with the study visit schedule for any reason.
- •Subject is currently participating in an investigational drug or device study or post market registry, or participated in another investigational drug or device study within one month prior to enrollment.
结局指标
主要结局
Effectiveness Endpoint
时间窗: During navigation portion of the procedure.
Successful robotic navigation of the guidewire and microcatheter is defined as reaching at least 95% of the predetermined anatomical target locations using the LIBERTY® Robotic System, without switching from a robotic to manual procedure due to difficulty reaching the target site.
次要结局
- Safety Endpoint(Through the three (3) day follow-up visit period.)