A Retrospective, Multi-Center, Real World Study of the BD Bard FLUENCY® PLUS Vascular Stent Graft in the Treatment of Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 6
- 主要终点
- Target Lesion Revascularization
研究概览
简要总结
This is a retrospective, multi-center study to assess the safety and performance by proactively reviewing pre-existing medical records and imaging of patients who had previous placement of FLUENCY® PLUS Vascular Stent Graft in iliac artery vessel(s) between January 2010 and March 2020.
详细描述
The purpose of this study is to retrospectively collect and analyze data on the FLUENCY® PLUS Vascular Stent Graft to summarize and describe real-world experience, and long-term data regarding its safety and efficacy and to compare these findings with published data on stent-treatment in iliac artery disease. The present study aims to collect clinical data about FLUENCY® treatment of atherosclerotic disease (stenosis, occlusion, dissection) as well as to explore safety and effectiveness data for off-label use in additional indications in the iliac segment that have been described in the scientific literature (vessel rupture, aneurysm).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •The FLUENCY® PLUS Vascular Stent Graft implantation procedure was for the purpose of lesions in the iliac arteries.
- •The FLUENCY® PLUS Vascular Stent Graft was placed between January 2010 and March
- •Male or female ≥ 18 years old at the time of implantation.
- •The subject provides written informed consent. The subject may be enrolled without informed consent for anonymous data collection if the responsible Ethics Committee has waived the requirement due to the retrospective study design, and written documentation about this decision is provided to the Investigator and the Sponsor.
排除标准
- •The FLUENCY® PLUS Vascular Stent Graft was implanted in an anatomic location other than iliac arteries.
- •Absence of a target lesion (i.e. diseased or damaged artery) in the area covered by the FLUENCY® PLUS Vascular Stent Graft.
- •Subjects without any existing follow-up information after hospital discharge (This criterion does not apply to subjects who deceased during implantation/prior to discharge).
- •The subject was identified with a medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol, or confound the data interpretation.
结局指标
主要结局
Target Lesion Revascularization
时间窗: 12 months
Target Lesion Revascularization (TLR) through 12-months post-index procedure.
Freedom from major complications
时间窗: 30 days
Freedom from device- and/or procedure-related death or myocardial infarction (MI), or any Target Lesion Revascularization (TLR), or target limb major amputation (above the ankle) through 30 days following the index procedure.
次要结局
- Target Vessel Revascularization(12 months, 24 months, 36 months, 60 months)
- Sustained Clinical Success(30 days, 12 months, 24 months, 36 months, 60 months)
- Technical Success(During Procedure)
- Procedural Success(From Procedure until patient is discharged from hospital (average of 2 days))
- Target Lesion Revascularization(24 months, 36 months, 60 months)
- Primary Patency(12 months, 24 months, 36 months, 60 months)
- Puncture site complications(From Procedure until patient is discharged from hospital (average of 2 days))