NCT03721939已完成不适用
BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Absence of clinically driven target lesion revascularization (CDTLR) at 12 months
研究概览
简要总结
The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients ≥ 18-year-old, with symptomatic lower extremity occlusive arterial disease
- •Rutherford class of symptom 2 to 5
- •Atheromatous ≥ 70 % stenosis or occlusion of SFA and/or PA
- •Absence of > 50% residual stenosis of the run-in vessels at the end of procedure
- •Presence of at least one patent (no ≥ 50 % stenosis) run-off tibial or fibular vessel to the foot at the end of procedure
- •De novo or restenotic lesions, including in-stent restenosis
- •Willingness to participate in the study and signature of informed consent
排除标准
- •Renal failure with glomerular filtration rate (GFR) 30 ml/min or below, estimated by the Cockroft-Gault equation.
- •Women who are pregnant, lactating, or planning to become pregnant during the duration of the study
- •Recent artery thrombosis, at risk of distal embolization during percutaneous procedure
- •Previous use of a PCB in the lesion during last 15 months
- •Extremely calcified lesions, defined by calcification involving ³ 270° of the artery circumference over ³ 15 cm.
- •Sub-intimal recanalization
- •Tortuous contra-lateral femoral access with difficult cross-over
- •Previous or planned surgery of the target lesion
- •High risk of bleeding
- •Contra-indication to dual antiplatelet therapy for one month, and/or to single antiplatelet therapy for 1 year
- •Allergy to aspirin, clopidogrel or heparin
- •Life expectancy less than one year
研究组 & 干预措施
FLEX Scoring Catheter plus DEB
Experimental
The target lesion is prepared by the FLEX Scoring Catheter® with a 30° rotation between each passage. Angioplasty is performed during 3 minutes with paclitaxel-coated balloon(s) (PCB), all along the target lesion.
干预措施: FLEX Scoring Catheter (Device)
结局指标
主要结局
Absence of clinically driven target lesion revascularization (CDTLR) at 12 months
时间窗: 12 months
Occurrence of death from cardiovascular origin
时间窗: 12 months
Occurrence of major amputation of target limb
时间窗: 12 months
次要结局
- Change in ankle brachial index (ABI)(3 and 12 months)
- Proportion of luminal gain(Average of 2 hours)
- Technical success of the scoring procedure(Average of 2 hours)
- Absence of CDTLR(3 months)
- Absence of major amputation(3 and 12 months)
- Change in Rutherford class of symptom(3 and 12 Months)
- Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan)(3 and 12 months)
- Occurrence of dissection(Average of 2 hours)
- Proportion of stent implantation(Average of 2 hours)
研究者
研究点 (1)
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