NCT04090320已完成不适用
A Prospective, Multi-Center, Single-Arm Study Assessing the Clinical Use of the CATERPILLAR™ Arterial Embolization Device System for Arterial Embolization in the Peripheral Vasculature (CHRYSALIS)
C. R. Bard6 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2019年9月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Technical Success
研究概览
简要总结
The primary objective of this study is to evaluate the performance and safety of the CATERPILLAR™ Arterial Embolization Device when used for arterial embolization in the peripheral vasculature.
详细描述
This feasibility study is a prospective, multi-center, single-arm study of the CATERPILLAR™ Arterial Embolization Device. Up to twenty (20) subjects will be treated with the CATERPILLAR™ Arterial Embolization Device at up to 5 investigational sites in New Zealand and Australia.
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
- •Clinical Inclusion Criteria:
- •Subject must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- •Subject must be either male or non-pregnant female ≥18 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
- •Subject must be willing and able to comply with protocol requirements, including all study visits and procedures.
- •Subject must require peripheral vascular occlusion at an arterial target embolization site(s) that can be treated with the CATERPILLAR™ Arterial Embolization Device according to the Instructions for Use (IFU). Note: More than one target embolization site may be treated per subject.
- •Angiographic Inclusion Criteria:
- •The target embolization site(s) must be located in a native arterial vessel(s) with the intended arterial vessel diameter ranges shown in the IFU, as assessed by the Investigator (via visual estimate).
- •The target embolization site(s) must have a landing zone sufficient to accommodate the device implant lengths shown in the IFU.
排除标准
- •The subject's access vessel(s) preclude safe insertion of the delivery catheter.
- •The subject's target embolization site(s) is located within a vein.
- •The subject's target embolization site(s) is located within the head, neck, heart or coronary vessels.
- •The subject's target embolization site(s) is located across highly locomotive joints or muscle beds (e.g. elbow, hip, knee, shoulder, thoracic inlet/outlet).
- •The subject's target embolization site(s) is located in a high-flow vessel where, in the opinion of the Investigator, there may be significant risk of migration and unintended (non-target site) occlusion.
- •The subject has a known allergy or hypersensitivity to contrast media that cannot be adequately pre-medicated.
- •The subject has a known allergy or hypersensitivity to any of the device materials including: cobalt, chromium, nickel, titanium, platinum, iridium, polyurethane or polyethylene.
- •The subject will receive anticoagulant or antiplatelet therapy (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) before, during and/or after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints.
- •The subject has a known uncontrolled blood coagulation or bleeding disorder.
- •The subject has an unresolved systemic infection.
- •The subject's required pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the Investigator, would clinically interfere with the study endpoints.
- •The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder, which, in the opinion of the Investigator, would clinically interfere with the study endpoints.
- •The subject has another medical condition which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, may confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
- •The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.
结局指标
主要结局
Technical Success
时间窗: Index Procedure.
Technical Success: Successful occlusion of the target embolization site(s) as confirmed by the Investigator via angiographic assessment during the Index Procedure. Technical success will be reported for each target embolization site.
Freedom from Device-Related SAEs
时间窗: 30 (-7/+21) Days
Freedom from Device-Related Serious Adverse Events (SAE) through 30 day follow-up.
次要结局
- Time Point of Occlusion(Index Procedure)
- Freedom from Recanalization(30 (-7/+21) Days)
- Freedom from Migration(30 (-7/+21) Days)
- Freedom from Device and/or Procedure-Related Adverse Events(30 (-7/+21) Days)
- Investigator Satisfaction(Index Procedure)
研究者
研究点 (6)
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