BIOTRONIK - A Prospective, International, Mulit-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 880
- 试验地点
- 45
- 主要终点
- Freedom from Major Adverse Events (MAE)
研究概览
简要总结
BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.
详细描述
The Passeo-18 LUX Paclitaxel Releasing BalloonCatheter is a novel drug-releasing balloon that received CE-mark in January 2014. Its safety and efficacy has been investigated in two randomized First-in-Man trials in patients with stenosis or occlusion of the femoropopliteal (BIOLUX P-I) and infrapopliteal (BIOLUX P-II) arteries when compared to an uncoated device.
The purpose of the BIOLUX P-III all-comers registry is to collect short and long-term clinical performance data on the Passeo-18 Lux DRB in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in daily clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age ≥ 18 years or minimum age as required by local regulations
- •Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable
- •Lesion(s) in the infrainguinal arteries suitable for endovascular treatment treated with or scheduled to be treated with the Passeo-18 Lux drug releasing balloon
排除标准
- •Life expectancy ≤ 1 year
- •Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet
- •Subject is pregnant or planning to become pregnant during the course of the study
- •Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations
结局指标
主要结局
Freedom from Major Adverse Events (MAE)
时间窗: 6 months
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically driven target lesion revascularization (TLR) within 6 months post-index procedure.
Freedom from clinically-driven Target Lesion Revascularization (TLR)
时间窗: 12 months
次要结局
- Freedom from clinically-driven TLR(6 and 24 months)
- Change in mean Ankle Brachial Index(6, 12 and 24 months)
- Freedom from MAE(12 and 24 months)
- Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire(6, 12 and 24 months)
- Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification(6, 12 and 24 months)
- Technical success(Day 0)
- Freedom from clinically-driven Target Vessel Revascularization (TVR)(6 and 24 months)
- Primary patency(12 and 24 months)
- Amputation-free survival(6, 12 and 24 months)
- Device success(Day 0)
- Procedural success(Participants will be followed for the duration of hospital stay, an expected average of 1-2 days)