NCT00444821终止不适用
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
Medtronic Cardiovascular65 个研究点 分布在 1 个国家目标入组 728 人开始时间: 2005年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 728
- 试验地点
- 65
- 主要终点
- Number of Subjects That Experienced Rupture or Aneurysm Related Death
研究概览
简要总结
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 to 90 years of age
- •Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use
- •Maximum aneurysm diameter of 4-5cm
- •If female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion
- •Patient is willing and able to comply with the specified follow-up evaluation
- •Life expectancy at least 3 years
排除标准
- •Meet any of the Contraindications stated in the Medtronic Vascular AAA Endograft instructions for Use
- •Known co-existing condition with a life expectancy of less than 3 years
- •Major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment
- •Subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before.
- •Planned conduit procedure for introduction of endograft
结局指标
主要结局
Number of Subjects That Experienced Rupture or Aneurysm Related Death
时间窗: 3 years
次要结局
- Aneurysm Growth >0.5 cm(1 year)
- Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up(study termination)
研究者
研究点 (65)
Loading locations...
相似试验
已完成
不适用
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)Acute Ischemic StrokeBasilar Artery OcclusionNCT06101667Beijing Tiantan Hospital224
已完成
不适用
Evaluation of STaged Endovascular Aneurysm Repair in the Management of Thoracoabdominal Pathology by Means of Branched and Fenestrated Devices.(STEAR)Thoracoabdominal AneurysmNCT03342755IRCCS San Raffaele50
已完成
不适用
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb IschemiaCritical Limb IschemiaNCT02060630Carelon Research1,843
Unknown
不适用
Efficacy and Safety Comparison of the Endovascular and the Hybrid Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type DIschemia LimbSuperficial Femoral Artery OcclusionPopliteal Artery OcclusionStent ComplicationAtherosclerosisNCT04590131Meshalkin Research Institute of Pathology of Circulation100
已完成
3 期
Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery OcclusionIschemic Stroke, AcuteThrombolysisEndovascular TreatmentNCT06221371Beijing Tiantan Hospital391