Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 114
- 试验地点
- 33
- 主要终点
- Single binomial proportion of successful delivery of the GPX Embolic Device to the target vessel embolization site(s)
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada.
详细描述
The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study. Subjects will undergo distal embolization in the peripheral vasculature, including vascular tumors, renal embolizations, and portal vein branches, with the GPX® Embolic Device and will then be followed 30-days post-procedure.
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
- •Age ≥18 years on the date of consent
- •Expected post-procedural lifespan of at least 30 days, in the opinion of the investigator, to allow for participation in all follow-up visits
- •Presents with need for peripheral embolization where there is a desire for distal vessel bed penetration including:
- •Vascular tumors (e.g., renal angiomyolipoma, renal cell carcinoma, bone tumors, bleeding tumors, and other vascular tumors)
- •Renal embolization
- •Portal vein branches
- •Informed consent granted by the patient or legally authorized representative
- •Willing and able to comply with the protocol-specified procedures and assessments
排除标准
- •Requires embolization for any of the following applications: a) Neurovasculature b) Coronary vasculature c) Hemorrhage due to trauma d) Non-tumoral focal/active bleeding sites (e.g., gastrointestinal tract, urinary tract, lung) e) Veins other than portal vein f) Aneurysms g) Endoleaks h) Vascular malformations i) Vessels for flow redistribution
- •Has undergone an embolization procedure within 30 days prior to consent
- •Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine)
- •Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents)
- •Known allergy or hypersensitivity to contrast media that cannot be adequately medicated
- •Pregnant, planning to become pregnant during the study period, or breastfeeding
- •Unresolved systemic infection or localized infection in the targeted region
- •Pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the investigator, would clinically confound the study primary endpoints
- •Existing medical condition which, in the opinion of the investigator, may cause the subject to be intolerant of an occlusion procedure or non-compliant with the protocol or may confound the data interpretation
- •Subject is participating in another device, drug, or procedure clinical investigation and has not completed the study treatment or the other investigation clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints)
- •Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
- •Patients with drug or alcohol dependency (within 6 months prior to study entry) that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or with the interpretation of study results
- •Intra-procedural exclusion criteria:
- •13. Presence of persistent, flow-limiting vasospasm that is not responsive to chemical or mechanical interventions
- •Presence of collateral pathways potentially endangering normal territories during embolization
- •Blood flow precludes safe delivery of embolic material (e.g., arteriovenous shunting or high, unpredictable flow exists)
- •Anatomy that precludes advancement of the delivery device to target vessel embolization site or delivery of embolic material
- •Dissection in the target vessel
- •The delivery device has already been used with an ionic contrast agent (e.g., Conray® (iothalamate meglumine injection USP 60%), Guerbet)
研究组 & 干预措施
GPX® Embolic Device
干预措施: GPX® Embolic Device (Device)
结局指标
主要结局
Single binomial proportion of successful delivery of the GPX Embolic Device to the target vessel embolization site(s)
时间窗: During procedure
Determined by the investigator at the time of enrollment
Freedom from major adverse events (MAEs)
时间窗: Index procedure through 30-day follow-up
MAEs are defined as: * Nontarget embolization with ischemia in an unintended anatomical area * Systemic allergic and/or toxic reaction to the GPX Embolic Device * Catheter entrapment and/or breakage * Culture-proven abscess in target organ/tissue * Embolization-related death
Single binomial proportion of successful occlusion of flow immediately beyond the target vessel embolization site(s)
时间窗: End of procedure
Determined by the core lab via comparison of the pre- and final post-embolization images
次要结局
- Occurrence of adjunctive embolization agent usage during the embolization procedure(End of procedure)
- Occurrence of device-related adverse events (AE) through 30 days post-index procedure(30-day follow-up)
- Occurrence of catheter occlusion due to the GPX Embolic Material(End of procedure)