The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study Using the Medtronic Assurant Cobalt Iliac Balloon-Expandable Stent System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD).
详细描述
This study is being conducted to collect 9 month safety and efficacy data on the Assurant Cobalt Iliac Stent for all subjects enrolled into the study.
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 lesion(s) is either de novo or restenotic in nature, located in the common iliac artery and/or the external iliac artery;
- •The subject is symptomatic (Fontaine stage II or III) with a target lesion stenosis ≥ 50% .
- •The target vessel(s) reference diameter is ≥ 6 mm and ≤ 10 mm by visual estimate;
- •The lesion length is < 100 mm (10 cm)
排除标准
- •Excessive peripheral vascular disease(PVD), unresolved fresh thrombus or tortuousity,or heavily calcified.
- •Tissue loss in the target extremities.
- •The target lesion is in a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;
- •The target lesion is in an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
- •The lesion requires treatment other than percutaneous transluminal angioplasty (PTA) prior to stent placement;
- •Other lesions requiring treatment or surgery within 30 days of the procedure (pre or post) with the exception of the non-target lesion(s).
- •Inadequate distal run-off.
- •History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
- •Creatinine > 2.5 mg/dl
- •Platelet count <80,000 cells/mm3 or >700,000 cells/mm3, or a white blood cell (WBC) of <3,000 cells/mm3
- •Participation in another investigational device or drug study and has not completed the primary endpoint(s) or that clinically interferes with the study endpoints;
- •Previously enrolled in the Study.
研究组 & 干预措施
Assurant Cobalt Iliac Stent
Assurant® Cobalt Iliac Stent System
干预措施: Assurant® Cobalt Iliac Stent System (Device)
结局指标
主要结局
Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).
时间窗: 9 months
Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.
次要结局
- Device Success(9 months)
- Lesion Success(9 months)
- Primary Patency Rate at 9 Months(9 months)
- Procedure Success(9 months)
- Clinical Success(9 months)
- Hemodynamic Success(9 months)
- All Cause Mortality(9 months)
- Clinical Success(30 days)
- Hemodynamic Success(30 days)
- All Cause Mortality(30 days)