VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- Treatment Success
研究概览
简要总结
The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October 1st, 2009.
The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections.
The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market approval.
详细描述
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Use of controls
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This study is a post-market registry without using a control. All analyses will be descriptive in nature and no statistical comparisons are planned.
Sample size 2. There is no sample size calculation since this is not a hypothesis driven study; VALIANT CAPTIVIA has recruited 100 subjects and will follow these subjects through for approximately 36 months. 2. Number of investigation sites and study duration
- 15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects.
- There will be no minimum nor maximum number of enrolled subjects per investigation site.
- The sites' compliance with the clinical investigation plan will be assessed on an ongoing basis. In case of serious non-compliance, the sponsor may decide to stop subject enrolment in a site based on the assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Treatment Success
时间窗: at 12 months
technical success and freedom from * TAA diameter increase of stented segment (\>5mm compared to 1 mo), * Types I/III endoleak, * Aneurysm rupture, * Conversion to open surgery, * Stent graft occlusion, * Stent graft migration resulting in SAE or secondary intervention.
Technical Success at Time of Initial Implant
时间窗: intraoperatively
Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system
次要结局
- SAE(through 12 months)
- ACM and ARM(at 30 days, 12 months, 24 months and 36 months)