NCT01499342已完成不适用
Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent to Treat Atherosclerotic Lesions in the Superficial Femoral Artery
be Medical2 个研究点 分布在 1 个国家目标入组 435 人开始时间: 2009年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 435
- 试验地点
- 2
- 主要终点
- Primary patency
研究概览
简要总结
This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed for a period of 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Signed informed consent
- •Stenosis (> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal and 4 cm proximal to the patella)
- •TASC II (2007)type A, B or C lesions
- •Target vessel diameter between 4.5 and 7 mm
- •Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
- •At least 1 outflow vessel down to the ankle
- •Patient is at least 18 years old
- •Life expectancy > 2 years
- •Patient is compliant with the requested follow-up visits
排除标准
- •No informed consent
- •Rutherford 6
- •TASC II type D lesions
- •Patient is not 18 years old
- •Patient is pregnant
- •Acute ischemia
- •Patient is not compliant with the requested follow-up visits
- •Unable to cross target lesion with guidewire
- •Patient is allergic to nickel-titanium
- •Presence of an aneurysm in the SFA
结局指标
主要结局
Primary patency
时间窗: 12, 24 months
Primary patency rate at 12 and 24 months as determined by Duplex ultrasound, defined as \<50% diameter restenosis(systolic velocity ratio no greater than 2.4) at the level of the treated lesion, without occurrence of target lesion revasularization between the index-procedure and the 12 and 24 months follow-up.
次要结局
- Secondary patency(12 and 24 months)
- Target lesion revascularization(12 and 24 months)
- Target vessel revascularization(12 and 24 months)
- Limb-salvage rate(12 and 24 months)
- Clinical success rate(12 and 24 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classificationPeripheral Vascular DiseaseNCT00496041University Hospital, Ghent205
已完成
不适用
Remedy, Biodegradable Peripheral Stent RegistryPeripheral Arterial DiseaseNCT01420120be Medical100
Unknown
不适用
A Prospective, Single-arm, Multi-centre, Observational, Real World RegistryAngina PectorisNCT02901353Meril Life Sciences Pvt. Ltd.400
招募中
不适用
A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab BetaNeuroblastomaNCT04253015EusaPharma (UK) Limited125
已完成
不适用
e-NOBORI Observational Registry of Nobori DESCoronary Artery DiseaseNCT01261273Terumo Europe N.V.18,000