NCT04365075招募中不适用
Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Target lesion revascularization rate
研究概览
简要总结
This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.
详细描述
This is a randomized study comparing excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •The treatment vessel is DeNovo
- •Stenotic (>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
- •Reference target vessel diameter between 2-4.0 mm by visual assessment
- •Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia
- •The patient must be >18 years of age
- •Life-expectancy of more than 12 months
- •The patient has no child bearing potential or negative serum pregnancy test
- •within 7 days of the index procedure
- •The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
- •The patient must provide written patient informed consent that is approved by the ethics committee
- •Anatomic Inclusion Criteria:
- •All inflow lesions successfully (<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications
- •At least one angiographically visible target at the ankle for establishment of straight line flow.
排除标准
- •Patient refusing treatment
- •The target vessel segment diameter is not suitable for available catheter design.
- •Unsuccessfully treated endovascular or bypass( >30% residual stenosis) proximal ( iliac, superficial femoral, popliteal) inflow limiting arterial/graft stenosis
- •Lesion lies within or adjacent to an aneurysm
- •The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
- •The patient has a history of prior life-threatening contrast media reaction.
- •The patient is currently enrolled in another investigational device or drug trial.
- •The patient is currently breast-feeding, pregnant or intends to become pregnant.
- •The patient is unable to provide informed consent
- •The patient has end stage renal disease (currently on any form of dialysis)
- •Known Left Ventricular Ejection Fraction < 35%
- •The patient has had a myocardial ischemia within 30 days prior to enrollment
- •The patient has had a cardiovascular accident within 90 days prior to enrollment
- •Serum Creatinine > 150 µmol
- •The patient has a previous bypass in the target limb
- •The patient has a current systemic infection
研究组 & 干预措施
Excimer Laser Combined with DCB
Experimental
Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.
干预措施: Excimer Laser Combined with DCB (Device)
Angioplasty Alone
Active Comparator
Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.
干预措施: Angioplasty Alone (Device)
结局指标
主要结局
Target lesion revascularization rate
时间窗: 6-months
Free target vascular occlusion and clinically driven target lesion revascularization rate confirmed by ultrasound examination.
次要结局
- hospitalization costs(6-months)
- Length of hospital stay(6-months)
- Major amputation rate(6-months)
- Incidence of major adverse events(6-months)
- Mortality(6-months)
- Ankle Brachial Index(6-months)
- transcutaneous oxygen pressure(6-months)
- Wound healing wagner score (for patients with Rutherford classification 5)(6-months)
研究者
研究点 (1)
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