Atrium iCAST Iliac Stent Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 49
- 主要终点
- Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis
研究概览
简要总结
Prospective, multicenter, non-randomized, single-arm registry to evaluate the safety and effectiveness of the iCAST Covered Stent System in the treatment of patients with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.
详细描述
STUDY DESIGN: Prospective, multicenter, non-randomized, single-arm registry
OBJECTIVE: The primary objective is to evaluate the iCAST covered stent to a performance metric derived from studies of FDA-approved iliac stent devices for treating iliac artery stenoses in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions.
PRIMARY ENDPOINTS: The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization or restenosis (by ultrasound determination) within 9 months post-procedure.
SECONDARY ENDPOINTS: Secondary endpoints include:
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
- •Subject is 18 years of age or older.
- •Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4).
- •Presence of de novo and/or restenotic lesions in the common and/or external iliac artery.
- •Subject has single, bilateral or multiple target lesions that is (are) ≥ 50% stenosed by visual estimate.
- •The target lesion(s) can be successfully crossed with a guide wire and dilated.
- •The target segment of subject's lesion(s) is between 5 and 12mm in diameter and less than 110 mm in length.
- •Subject has angiographic evidence of a patent profunda or superficial femoral artery (SFA) in the target limb.
- •Subject has provided written informed consent.
- •Subject is able and willing to adhere to the required follow-up visits and testing through month
- •Subject is able and willing to adhere to the required follow-up medication regimen.
排除标准
- •Presence of other non-target ipsilateral arterial lesions requiring treatment within 30 days post-procedure (Note that treatment of ipsilateral SFA lesions may be allowed under certain circumstances). Treatment of lesions in any other vascular bed must be completed at least 30 days prior to enrollment.
- •The target lesion(s) has adjacent, acute thrombus.
- •The target lesion(s) is highly calcified or was previously treated with a stent.
- •Target lesion involves the internal iliac artery resulting in crossing of the side-branch with the iCAST device (e.g. "jailing" of the side-branch).
- •Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion.
- •Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to initiation of the iCAST implant procedure.
- •Subject has a post-surgical stenosis and anastomotic suture treatments of the target vessel.
- •Subject has a vascular graft previously implanted in the native iliac vessel.
- •Subject has tissue loss, defined as Rutherford-Becker classification category 5 or
- •Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
- •History of neutropenia (WBC <3,000/mm3), coagulopathy, or thrombocytopenia (platelet count <80,000/ μL) that has not resolved or has required treatment in the past 6 months.
- •Known bleeding or hypercoagulability disorder or significant anemia (Hb< 8.0) that cannot be corrected.
- •Subject has the following laboratory values:
- •platelet count less than 80,000/ μL,
- •prothrombin time (PT)/partial thromboplastin time (PTT) not within normal limits
- •serum creatinine level greater than 2.5 mg/dL
- •Subject requires general anesthesia for the procedure.
- •Subject is pregnant.
- •Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
- •Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. Note: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.
结局指标
主要结局
Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis
时间窗: Within 9 Months post-procedure
The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months.
次要结局
- Device Success(Post-procedure)
- Early Clinical Success(1 Month)
- Acute Procedural Success(Post-procedure)
- Major Adverse Vascular Event (MAVE)(360 Days)
- Primary-Assisted Patency(36 Months)
- Secondary Patency(36 Months)
- Major Adverse Event (MAE)(30 Days)
- Late Clinical Success(36 Months)
- Primary Patency(36 Months)