SIGNATURE Study: Post-market, Randomized Controlled, Multicenter, Single Blinded Prospective Trial Investigating the Paclitaxel-Coated Balloon (Legflow DCB) Treatment Versus Uncoated Balloon Angioplasty Treatment for Femoro-popliteal Lesions.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 6
- 主要终点
- Primary Efficacy Endpoint:
研究概览
简要总结
The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease (PAD) due to stenosis, restenosis or occlusion of the femoral and/or 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Efficacy Endpoint:
时间窗: 12 months post-procedure
The primary efficacy endpoint is time to clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any reintervention at the target lesion due to symptoms OR drop of ankle brachial index (ABI) \> 20 % OR ABI \> 0.15 compared to the post-procedural ABI.
Device- and procedure-related death
时间窗: 30 days post-procedure
Primary Safety Endpoint: Freedom from device- and procedure-related death through 30 days post-index procedure;
Major target limb amputation and clinically-driven target vessel revascularization
时间窗: 12 months post-procedure
Primary Safety Endpoint: A composite of (2.1) time to major target limb amputation (above-the-ankle (ATA)) through 12 months post-procedure and (2.2) time to clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure
次要结局
- Acute device success(during index procedure)
- Target Vessel Revascularization at 6-, 12- and 24-months post-index procedure(6, 12, 24-months post-procedure)
- Secondary safety endpoint at discharge up to 30 days post-index procedure(30 days post-operative)
- Sustained clinical improvement at 6-, 12- and 24- months post-index procedure(6, 12, 24-months post-procedure)
- Acute procedural success(during index procedure)
- Binary restenosis at 6-, 12- and 24-months(6, 12, 24-months post-procedure)
- Change in target limb Rutherford Classification from baseline to 6-, 12- and 24-months(6, 12, 24-months post-procedure)
- device- and procedure-related death(30- days, 6, 12, 24-months post-procedure)
- Primary Patency at 6-, 12- and 24-months(6, 12, 24-months post-procedure)
- Target Lesion Revascularization at 6-, 12- and 24-months post-index procedure(6, 12, 24-months post-procedure)
- Thrombosis at the target lesion at 6-, 12- and 24-months(6, 12, 24-months post-procedure)
- Major Adverse Events (MAEs) at 6-, 12- and 24-months post-index procedure(6, 12, 24-months post-procedure)
- Change in Target Limb Resting ABI or TBI from baseline to 6-, 12- and 24-months(6, 12, 24-months post-procedure)
- Improvement of life quality according to the Walking Impairment Questionnaire (WIQ) and the EQ-5D Questionnaire to baseline at follow-up at 6-, 12- and 24-month.(6, 12, 24-months post-procedure)
- Major Target Limb Amputation at 6-, 12- and 24-months(30- days, 6, 12, 24-months post-procedure)
- All-cause death at 6-, 12- and 24-months(30- days, 6, 12, 24-months post-procedure)