NCT01016275已完成不适用
Physician Initiated Multi-center Belgian-German Trial Investigating the Terumo Misago Stent in the Treatment of TASC A & B Iliac Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Primary patency, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without Target Lesion Revascularization (TLR) within 12 months.
研究概览
简要总结
The objective of this clinical study is to evaluate, in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol rapid-exchange Misago (Terumo) stent in TASC A and B iliac lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator)
- •Patient presenting a score from 2 to 5 following Rutherford classification
- •Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
- •Patient is >18 years old
- •Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- •Patient is eligible for treatment with the Misago (Terumo)
- •The target lesion is either a modified TASC-II class A or B lesion with one of the listed specifications:
- •Type A lesions
- •Unilateral or bilateral stenoses of the Common Iliac Artery
- •Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery
- •Type B lesions
- •Unilateral Common Iliac Artery occlusion
- •Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not extending into the Common Femoral Artery
- •Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery
- •The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
- •There is angiographic evidence of a patent Common an Deep Femoral Artery
排除标准
- •The target lesion is either a modified TASC-II class B lesion with aortic lesion involvement:
- •Short (≤3 cm) stenosis of infrarenal aorta
- •The target lesion is either a modified TASC-II class C or D lesion with aortic lesion involvement:
- •Presence of aneurysm at the level of the iliac arteries
- •Previously implanted stent(s) at the same lesion site
- •Reference segment diameter is not suitable for available stent design
- •Untreatable lesion located at the distal outflow arteries
- •Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
- •Patients refusing treatment
- •Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- •Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
- •Perforation at the angioplasty site evidenced by extravasation of contrast medium
- •Patients with a history of prior life-threatening contrast medium reaction
- •Patients with known hypersensitivity to nickel-titanium
- •Patients with uncorrected bleeding disorders
- •Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- •Life expectancy of less than twelve months
- •Any planned surgical intervention/procedure within 30 days of the study procedure
- •Any patient considered to be hemodynamically unstable at onset of procedure
- •Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
结局指标
主要结局
Primary patency, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without Target Lesion Revascularization (TLR) within 12 months.
时间窗: 12 months
次要结局
- Clinical success, defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification(1, 12 & 24 months)
- Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without prior TLR are defined as being primary patent at the given follow-up.(1 & 24 months)
- Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30%.(procedural)
- Serious adverse events(up to 24 months)
研究者
研究点 (5)
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