NCT00678249已完成不适用
A Prospective, Multi-Center, Randomized Evaluation of an IMPRA/Bard ePTFE Encapsulated Carbon Lined Nitinol Endoluminal Device for AV Access Graft Stenoses
C. R. Bard1 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2001年1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
- 227
- 试验地点
- 1
- 主要终点
- Percent of Participants With Treatment Area Primary Patency (TAPP)
研究概览
简要总结
This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.
详细描述
A total of 227 patients were treated at 16 U.S. investigational sites to evaluate the safety and effectiveness of the FLAIR™ Endovascular Stent Graft. This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between 18 to 90 years of age whose hemodialysis access was a synthetic AV access graft located in an arm.
- •Angiographic evidence of one or more stenoses, 7 cm or less in length and greater than or equal to 50%, at the graft-vein anastomosis of a synthetic AV access graft. The entire lesion must have been located within 7 cm of the anastomosis such that approximately 1 cm of the IMPRA/Bard Device must have extended into non-diseased vein and approximately 1 cm, but no more than 2 cm, of the IMPRA/Bard Device will be extended into non-diseased AV graft.
- •Clinical evidence of a hemodynamically significant stenosis.
- •Percutaneous endovascular therapy for the identified lesion was the best treatment choice in the opinion of the investigator.
- •Patients must have been able to understand and provide informed consent.
- •Patients whose synthetic AV access grafts had been implanted greater than 30 days and had undergone 1 or more successful hemodialysis sessions.
- •During primary balloon angioplasty, full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, must have been achieved.
排除标准
- •Concomitant disease (e.g., terminal cancer) or other medical condition that was likely to result in death of the patient within 6 months of the time of implantation.
- •Stenoses that had a corresponding thrombosis treated within 7 days.
- •The presence of a second lesion in the access circuit less than or equal to 3 cm from the edges of the primary lesion that was treated within 30 days or that was greater than or equal to 30%. Access circuit was defined as the area from the AV access graft arterial anastomosis to the superior vena cava-right atrial junction.
- •The presence of a second lesion in the access circuit greater than 3 cm from the edges of the primary lesion that was greater than or equal to 30%. Second lesions that were greater than or equal to 30% must have been treated prior to patient inclusion to reduce the percent stenosis to less than 30%.
- •Patients who were unwilling or unable to return for follow-up visits or patients with whom follow-up visits may have been unreliable.
- •Patients who had a stent placed at the target lesion site.
- •Patients with a blood coagulative disorder or sepsis.
- •Patients in which the IMPRA/Bard Device would have been required to cross an angle (between the inflow vein and synthetic AV access graft) that was greater than 90 degrees.
- •Patients in which the IMPRA/Bard Device would have been required to be deployed fully across the elbow joint, which is identified radiographically by a combination of the humeroulnar joint and the humeroradial joint.
- •Patients with a contraindication to the use of contrast media.
- •Patients whose AV access graft was infected.
- •Patients who were currently or were scheduled to enroll in other investigations that conflicted with follow-up testing or confounds data in this trial.
- •Procedural use of another investigational device.
- •Patients who were pregnant.
结局指标
主要结局
Percent of Participants With Treatment Area Primary Patency (TAPP)
时间窗: 6 month follow-up
TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.
次要结局
- Total Number of Adverse Events(6 month Follow-Up)
- Percent of Participants With Successful Delivery of the Device(Index Procedure)
- Percent of Participants With Procedural Success(Index Procedure)
- Percent of Participants With TAPP(2 month Follow-Up)
- Percent of Participants With Access Circuit Primary Patency (ACPP)(6 month Follow-Up)
- Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)(6 month Follow-Up)
- Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)(6 month Follow-Up)
- Percent of Participants With Binary Restenosis(6 month Follow-Up)
研究者
研究点 (1)
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