NCT04244370已完成不适用
A Prospective, Multi-Center, Single-Arm, Real World Study Assessing the Clinical Use of the Caterpillar™ Arterial Embolization Device for Arterial Embolization in the Peripheral Vasculature (MONARCH)
C. R. Bard22 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年4月30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
- 50
- 试验地点
- 22
- 主要终点
- Freedom From Device-Related SAEs
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 in a real world, on-label application.
详细描述
The post-market study is a prospective, multi-center, single-arm, real world study of the Caterpillar™ Arterial Embolization Device. Enrollment will continue until up to fifty (50) subjects have been treated with the Caterpillar™ Arterial Embolization Device at up to 20 investigational sites in the United States.
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
- •Subject or Legally Authorized Representative (LAR) must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study-specific data or performance of study-specific 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: Per Investigator discretion, up to five (5) Target Embolization Sites may be treated with up to ten (10) study devices 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 has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy 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
Freedom From Device-Related SAEs
时间窗: 30 (-7/+21) Days post Index Procedure
Freedom from device-related serious adverse events (SAE) through 30-day follow-up.
Technical Success
时间窗: During the Index Procedure
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.
次要结局
- Time Point of Occlusion(During Index Procedure)
- Freedom From Acute Migration(During Index Procedure)
- Freedom From Non-Acute Migration(30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure)
- Freedom From Device and/or Procedure-Related Adverse Events(30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure)
- Freedom From Recanalization(30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure)
- Accuracy of Delivery(During Index Procedure)
- Ease of Trackability/Deliverability(During Index Procedure)
- Ease of Detachment(During Index Procedure)
- Acceptability of Visibility Under Fluoroscopy(During Index Procedure)
研究者
研究点 (22)
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