Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy: the FESTIVAL Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
Prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive disease of the common femoral artery
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with peripheral arterial disease (Rutherford class 3-6)
- •Presence of a steno-obstructive lesion of the common femoral artery (Azema classification 1-3)
- •Possible endovascular treatment of both the iliac axis and/or femoro-distal vessels
- •Possible post-dilatation with plain or drug-coated balloon angioplasty
排除标准
- •Concomitant open surgery (ilio-femoral or femoro-distal bypass)
- •Presence of a steno-obstructive lesion of the common femoral artery in previous open surgery (Azema classification 4)
- •Presence of a steno-obstructive lesion of the common femoral artery after a previous endovascular procedure
结局指标
主要结局
Technical success
时间窗: Intraprocedural
insertion/use of the device after crossing the steno-obstructive lesion and its removal without complications, restoration of vessel patency in the absence of stenosis/acute recoil \>30%, rupture/perforation of the common femoral artery, need for a bailout stenting
Secondary patency
时间窗: 1 month / 6 months / 1 year
patency of the treated vessel after occlusione and treatment by surgical or endovascular means
Clinical success
时间窗: Intraprocedural / 1 month
absence of intraprocedural complications including distal embolization and improvement of at least 1 Rutherford class assessed 1 month after the procedure
Primary assisted patency
时间窗: 1 month / 6 months / 1 year
patency of the treated vessel after one or more endovascular reinterventions
Clinically driven freedom from target lesion restenosis (cdTLR)
时间窗: 1 month / 6 months / 1 year
restenosis resulting in vessel occlusion or stenosis with maximum PSV \> 2.5 m/sec
Primary patency
时间窗: 1 month / 6 months / 1 year
patency of the treated vessel in the absence of a restenosis \>30%
次要结局
- Limb salvage(1 month / 6 months / 1 year)
- Freedom from any reinterventions(1 month / 6 months / 1 year)
- Patency of profunda femoris(1 month / 6 months / 1 year)
研究者
Nicola Troisi
Associate Professor of Vascular Surgery
University of Pisa