NCT00718991终止2 期
A Physician Initiated Prospective Multicenter Study on Excimer Laser Recanalisation in the Treatment of Long Infrapopliteal Lesions in Patients With Critical Limb Ischemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization
研究概览
简要总结
This investigation is designed to assess the immediate and long-term angiographic patency outcomes of excimer laser recanalisation followed by PTA in the treatment of long (>50 mm) infrapopliteal lesions in patients with critical limb ischemia (CLI)
The Spectranetics Turbo elite™ excimer laser catheters are percutaneous intravascular devices constructed of multiple optical fibers around a guidewire lumen. The laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photo-ablate fibrous, calcific and atheromatous lesions, thus recanalizing diseased vessels.
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
- •The treatment vessel is DeNovo
- •Stenotic (>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
- •Length of target lesion is > 50 mm
- •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, SFA, 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 an MI within 30 days prior to enrollment
- •The patient has had a CVA 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
结局指标
主要结局
Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization
时间窗: 6 months
Angiographic patency for laser + PTA, as defined by < 50% stenosis in the target lesion with straight line flow to the foot
时间窗: 12 months
次要结局
- Immediate angiographic laser recanalization success + PTA, defined as a residual diameter stenosis ≤30% and absence of flow-limiting dissection on visual assessment after combined excimer laser and PTA recanalization treatment(Procedure)
- Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization(12 months)
- Limb-salvage rate at all follow-up visits, defined as lack of major amputation of treated limb. Limb-salvage rate (LSR) is defined as 1 minus major amputation rate(12 months)
- Serious adverse events defined as being fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged or new hospitalization(12 months)
- Clinical success at follow-up is defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification(12 months)
- Health Economics assessment being: length of hospital stay, duration of the procedure, unplanned visits, retreatment and diagnostic procedure codes, material and medication costs(12 months)
研究者
研究点 (4)
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