NCT03052309已完成不适用
BIOTRONIK - A Prospective, International, Multi-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Popliteal Arteries - III BENELUX
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
- 106
- 试验地点
- 9
- 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 BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries
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
- •Lesion(s) in the popliteal arteries suitable for endovascular treatment, treated with or scheduled to be treated with the Passeo-18 Lux drug coated balloon.
- •Isolated popliteal artery lesion: at least 2 cm of healthy segment between lesion(s) in the popliteal artery and lesion(s) in distal superficial femoral artery
- •Inflow free from flow-limiting lesion. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion(s) have been treated successfully before or during the index procedure, with a maximum residual stenosis of 30% per visual assessment
- •At least one native artery with direct outflow artery to the foot
- •Rutherford classification 2-5
- •Patient with bypass surgery in the same limb can be enrolled if there is at least 2 cm healthy segment between popliteal artery and anastomosis
排除标准
- •Life expectancy ≤ 1 year
- •Rutherford classification 6
- •Lesion involving the superficial femoral artery (arterial intersection with the femur in an anteroposterior view) or extending in infra-popliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk)
- •Aneurysm at the level of the popliteal artery
- •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)
- •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
结局指标
主要结局
Freedom from Major Adverse Events (MAE)
时间窗: 6 months
Freedom from Major Adverse Events (MAE): 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 (cd-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
- Freedom from clinically-driven target vessel revascularization (TVR)(6, 12 and 24 months)
- Change in mean Ankle Brachial Index (ABI)(6, 12 and 24 months)
- Device success(immediately upon index procedure)
- Technical success(immediately upon index procedure)
- Freedom from Major Adverse Events (MAE)(12 and 24 months)
- Walking Impairment Questionnaire(6, 12 and 24 months)
- Primary patency(12 and 24 months)
- Improvement in Rutherford classification(6, 12 and 24 months)
- Amputation-free survival (AFS)(6, 12 and 24 months)
- Freedom from clinically-driven target lesion revascularization (cd-TLR)(6 and 24 months)
- Pain score(6, 12 and 24 months)
- Procedural success(immediately upon discharge)
研究者
研究点 (9)
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