NCT00614315已完成不适用
A Prospective Observational Study of the FLAIR™ Endovascular Stent Graft Optimized Delivery System
C. R. Bard2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年12月1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
- 30
- 试验地点
- 2
- 主要终点
- Technical Success for Delivery
研究概览
简要总结
The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™ Delivery System.
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
- •The subject is either a male or non-pregnant female ≥ 18 years old.
- •The subject has been properly informed about the study per IRB requirements, and has signed and dated the IRB-approved ICF.
- •The subject is willing to comply with the protocol requirements and can be contacted by telephone.
- •The subject has a synthetic AV access graft located in an arm that has been implanted for > 30 days and has undergone at least one successful dialysis session prior to the index procedure.
- •Angiographic evidence indicates that the subject has a stenosis of >50% located at the graft-vein anastomosis of the subject's synthetic AV access graft.
- •The target lesion is estimated to be ≤ 7 cm in length by angiography prior to performance of any interventional procedures.
- •The entire target lesion is located within 7 cm of the graft-vein anastomosis, as verified by angiography, such that approximately 1 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased vein and approximately 1 cm but no more than 2 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased AV graft.
- •Graft diameter at the deployment site is between 5 mm and 8 mm, as verified by angiography.
- •Full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty.
排除标准
- •The subject has a life expectancy of < 6 months.
- •The presence of a previously placed stent and/or stent graft located in the treatment area. The treatment area is defined as the entire target lesion and 1 cm of landing zone into both non-diseased AV graft and non-diseased vein.
- •The subject has an infected AV access graft or other infection.
- •The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft be deployed fully across the elbow joint.
- •The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft cross an angle (between the outflow vein and synthetic AV access graft) that is > 90 degrees.
- •The subject has an uncorrected blood coagulation disorder.
- •The subject has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated.
- •Subject is currently enrolled or scheduled to be enrolled in other investigations that conflict with follow-up testing or confounds data in this trial.
- •The subject has a known hypersensitivity to nickel-titanium.
结局指标
主要结局
Technical Success for Delivery
时间窗: Measured at the time of implantation (Day 0)
defined as deployment of the implant to the intended location, assessed at the time of the index procedure.
次要结局
- Number of Device/Procedure-related Adverse Events(Safety of Delivery)(Index Procedure to 30 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Post-Approval Study for the FLAIR Endovascular Stent GraftStenosis of Vascular Prosthetic Devices, Implants and GraftsNCT00677235C. R. Bard270
已完成
不适用
Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ ProlapseCystoceleRectoceleEnteroceleNCT00833001Ethicon, Inc.126
Unknown
不适用
Rational Fluid Therapy in GermanyPatients in ICUNCT01122277Ludwig-Maximilians - University of Munich4,000
招募中
不适用
Evaluation of ADM(SC Derm® Recon) in Breast ReconstructionBreast Cancer FemaleNCT06553859DOF Inc.100
尚未招募
2 期
Treatment of Epidermoid CystsEpidermoid CystNCT05597995Goldman, Butterwick, Fitzpatrick and Groff10