NCT04323033已完成不适用
Prospective, Randomized Clinical Trial Evaluating Safety and Efficacy of Cobalt-chromium Sirolimus Eluting Stent (PERS) by Balton Versus Cobalt-chromium Stent (Neptune C), to Maintain Patency of Iliac Arteries in Patients Undergoing Peripheral Angioplasty
Balton Sp.zo.o.6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Occurrence of MAE
研究概览
简要总结
The aim of this study is to assess the safety and efficacy of PAD treatment by revascularization with new cobalt-chromium sirolimus stent implantation, which is expandable on balloon PERS (CoCr SES) compared to cobalt-chromium balloon-expandable (Neptun C) stent (CoCr BMS) in patients with symptomatic iliac arteries disease requiring revascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •De novo lesion or restenosis without previously implanted stent, in a common or external iliac artery with a reference diameter of 5 to 12 mm, length up to 10 cm and stenosis ≥ 50% and ≤ 99% (in quantitative assessment by peripheral angiography), which may be treated with one stent or total occlusion of vessels up to 50 mm long.
- •Ability to cross the lesion with guidewire (assessed during diagnostic angiography).
- •ABI ankle-brachial index <0.
- •Signs of lower limb ischemia based on the Rutherford scale in the range from 2 to
- •Age ≥ 18 years.
- •Patient signed informed consent form.
排除标准
- •Life expectancy less than two years.
- •Chronic kidney disease in stage III-V.
- •Lesion in the previously implanted by-pass.
- •Target lesion is a chronic total occlusion of significant length, not eligible for percutaneous revascularization.
- •Acute lower limb ischemia.
- •Stenosis (> 50%) or occlusion proximally to the lesion being treated.
- •Angiographically confirmed thrombus in the lesion to be treated.
- •Treatment requires an atherectomy to deliver stent to treated lesion.
- •Known allergy or hypersensitivity to clopidogrel.
- •Hemorrhagic stroke in the last three months.
- •Contraindications for acetylsalicylic acid (hypersensitivity, hemorrhagic diathesis).
- •Pregnancy or women of childbearing potential not using effective contraception.
- •Active inflammation at the planned access site.
结局指标
主要结局
Occurrence of MAE
时间窗: 12 months FU
Occurrence of major adverse event (MAE) in 12 months follow up, defined as death related to stent implantation of procedure, amputation above metatarsus in treated limb due to vascular complication or/and reintervention in treated lesion (TLR).
次要结局
- Vessel patency(30 days, 6 months and 12 months FU)
- Success of implanting the device(Directly after implantation, at the end of endovascular index procedure)
- Clinical success(During follow-up visits: 30 days, 6 months and 12 months)
- ABI (ankle-brachial index) change(30 days and 12 months FU)
- Mortality rate(30 days, 6 months and 12 months FU)
- Artery patency in Duplex Doppler USG: Maximum velocity flow(30 days, 6 months and 12 months FU)
- Artery patency in Duplex Doppler USG: % of diameter stenosis(30 days, 6 months and 12 months FU)
- Procedural success(Up to 7 days after procedure)
研究者
研究点 (6)
Loading locations...
相似试验
Unknown
不适用
Effectiveness of Platelet-rich Plasma for Treatment of Trigger FingerTendon EntrapmentNCT04167098Töölö Hospital117
已完成
不适用
Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial DiseasePeripheral Arterial DiseaseNCT01588067Kaiser Permanente271
已完成
不适用
Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSEMultiple SclerosisNCT01450072State University of New York at Buffalo20
进行中（未招募）
不适用
Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular RepairVascular DiseasesNCT03173703LeMaitre Vascular144
已完成
2 期
Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery DiseaseHeart DiseaseMyocardial IschaemiaCoronary DiseaseCoronary Artery DiseaseNCT01035567Silesian Centre for Heart Diseases200