NCT03052296已完成不适用
BIOTRONIK - A Prospective, National, Multi-centre, Post-market Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Long Femoropopliteal Artery Lesions - III SPAIN
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Freedom from Major Adverse Events (MAE)
研究概览
简要总结
The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily clinical practice
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
- •Age ≥ 18 years or minimum age as required by local regulations
- •Subject must be willing to sign a Patient Data Release Form (PDRF) or Patient Informed Consent (PIC) where applicable
- •Subject classified as Rutherford class 4, 5 or 6
- •TASC C or D lesion(s) in the femoropopliteal artery
- •Lesion length > 15 cm 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 its primary endpoint yet.
- •Subject is pregnant or planning to become pregnant during the course of the study.
- •Rutherford class <4
- •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).
- •Intraprocedural decision not to proceed with the Passeo18 Lux DCB for any reason not related to the device (for instance blood flow limiting dissection after predilatation).
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, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR)
Freedom from clinically driven Target Lesion Revascularization (TLR)
时间窗: 12 months
Any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.)
次要结局
- Primary Patency(12 months)
- Walking Impairment Questionnaire compared to the pre-procedure score(6 and 12 months)
- Device success(Immediately upon procedure)
- Freedom from clinically-driven target vessel revascularization (TVR)(6 and 12 months)
- Freedom from clinically-driven target lesion revascularization (TLR)(6 months)
- Freedom from MAE(12 months)
- Technical success(Immediately upon procedure)
- Amputation-free survival (AFS) including major, minor and overall AFS(6 and 12 months)
- Pain score compared to the pre-procedure score(6 and 12 months)
- Improvement in Rutherford classification compared to the pre-procedure Rutherford classification(6 and 12 months)
- Procedural success(Immediately upon discharge)
- Change in mean Ankle Brachial Index (ABI)(6 and 12 months)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
不适用
BIOLUX P-III BENELUX All-Comers RegistryPeripheral Arterial DiseaseNCT03052309Biotronik AG106
已完成
不适用
BIOLUX P-III All-Comers Passeo-18 Lux RegistryAtherosclerosisPeripheral Artery DiseaseNCT02276313Biotronik AG880
已完成
不适用
Retrospective Follow-up of BIOLUX P-I/-IIOverall MortalityNCT04250909Biotronik AG132
终止
不适用
Plexa ICD Lead RegistryImplantable Defibrillator UserNCT03103503Biotronik, Inc.901
终止
不适用
BIOSOLVE-IV Magmaris Swiss Satellite RegistryCoronary Artery DiseaseNCT04025788University Hospital, Geneva10