ACTRN12614000504617已完成不适用
Clinical evaluation of the performance and safety of the Zilver PTX stent thumbwheel delivery system in the treatment of symptomatic peripheral arterial disease of the above-the-knee femoropopliteal arteries.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •A patient is deemed suitable for inclusion in the study if the patient meets the following criteria:
- •1. One atherosclerotic lesion of the above-the-knee femoropopliteal artery with >50% angiographically-documented stenosis
- •2. Reference vessel diameter of 4-7 mm
- •3. Symptomatic for peripheral arterial disease classified as Rutherford Category 2-4
排除标准
- •Patients are excluded from enrollment into the study if any of the following are true:
- •General Exclusion Criteria
- •1. Unable or unwilling to sign and date informed consent
- •2. Less than 18 years of age
- •3. Unable or unwilling to comply with follow-up schedule
- •4. Simultaneous participation in another investigational drug or device study. The patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study.
- •5. Pregnant, breastfeeding or planning to become pregnant in the next 5 years.
- •6. Medical condition or disorder that would limit life expectancy < 30 days
- •7. Prior stent in the study vessel
- •8. Underwent any surgical or interventional procedure within 30 days prior to the study procedure.
- •9. Planned surgical or interventional procedure within 30 days after the study procedure.
- •10. Contraindication to antiplatelet or anticoagulant medications
- •11. Known hypersensitivity or contraindication to study products (note: study products not limited to device materials, contrast, and antiplatelet or anticoagulant medications).
- •12. Unresolved systemic or local infection which could affect the clinical study outcomes.
- •13. Significant stenosis (>50%) or occlusion of inflow tract (proximal ipsilateral iliofemoral or aortic lesions) not successfully treated before this procedure (success is measured as < 30% residual stenosis).
- •14. Lacks at least one patent runoff vessel with < 50% stenosis; if runoff vessel is treated prior to the procedure the treatment must be successful with < 30% residual stenosis.
- •15. Untreated angiographically-evident thrombus in the target lesion.
- •16. Lesion requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery.
研究者
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