NCT00613418撤回不适用
Comparative Study of Safety and Efficacy of the SUPERA® Wire Interwoven Self-expanding Nitinol Stent and Currently Approved Stents for Patients With Iliac Lesions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Target site revascularization or restenosis
研究概览
简要总结
This is a prospective, multicenter, non-randomized, single-arm trial; the primary objective is to assess the comparability of the performance of the IDev SUPERA® nitinol stent to a rate derived from a meta-analysis of studies on iliac stents approved by FDA for treating subjects with de novo or restenotic lesions in the common and/or external iliac arteries.
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 and of legal age of consent.
- •Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2, 3 or 4).
- •Subject has de novo or restenotic lesions in the common 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 4 and 10 mm in diameter and less than 110 mm in length.
- •Subject has angiographic evidence of a patent femoral outflow artery 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 arterial lesions requiring treatment within 30 days of the procedure.
- •The target lesion(s) has adjacent, acute thrombus.
- •The target lesion(s) is highly calcified or was previously treated with a stent.
- •Subject has a pre-existing target iliac artery perforation or dissection of the target iliac artery prior to initiation of the IDev implant procedure.
- •Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion. Subject has a pre-existing aneurysm or dissection of the target iliac segment.
- •Subject with aortic or iliac aneurysm that is likely to require repair within the next 9 months.
- •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 is unable to accommodate ≥ 7 Fr cat
- •Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has a hypersensitivity to nickel, or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
- •Subject has history of neutropenia (WBC <3,000/mm3).
- •Subject has coagulopathy or thrombocytopenia (platelet count <80,000/ μL) that has not resolved or has required treatment in the past 6 months.
- •Subject has known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0 g/dL) that cannot be corrected.
- •Subject has the following laboratory values:
- •international normalized ratio (INR) greater than 1.5,
- •serum creatinine level greater than 2.5 mg/dL.
- •Subject requires general anesthesia for the procedure.
- •Subject is pregnant or plans to become pregnant during the study.
- •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.
研究组 & 干预措施
single
Other
Historical control
干预措施: IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System (Device)
结局指标
主要结局
Target site revascularization or restenosis
时间窗: 9 months
Occurrence of death
时间窗: within 30 days post-procedure
次要结局
- Target vessel patency(6, 9, 12, 24, and 36 months)
- Quality of Life questionnaire(baseline, 3 and 6 months)
- Major adverse events (MAEs)(30 days)
- Device success (delivery and deployment of the study stent and retrieval of the delivery system)(During implantation procedure)
- Acute procedural success(immediately following stent deployment)
- Early and late clinical success (Rutherford-Becker improvement); ABI and TBI improvement; symptom based.(30 days and 6, 9, and 12 months)
研究者
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