NCT02939924已完成不适用
Prospective, Multi-Center, Open, Single Arm Study for the Treatment of Patients Presenting De Novo Lesions in the Superficial Femoral and/or Popliteal Arteries Using a Kanshas Drug Coated Balloon Catheter.
Terumo Europe N.V.6 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2017年4月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- The primary outcome measure of the study is a composite of freedom from device and procedure related deaths through 30 days, freedom from target limb amputation, and clinically driven target lesion revascularization (TLR) through 6 months.
研究概览
简要总结
Assessing the safety and effectiveness of the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.
详细描述
The KANSHAS 1 (K-1) trial investigates the inhibition of restenosis using the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral and/or popliteal arteries.
This clinical study is a prospective, multi-center, open, single-arm study. Up to 50 patients will be enrolled at 2 sites in Belgium and 4 sites in Germany. Follow-ups are scheduled before discharge, at 1 month (Clinic Visit or Phone FU), 6 months, 1-year, 2-years (Clinic Visits), 3-, 4- and 5- years (Clinic Visits or Phone FU).
Primary outcome measure:
- freedom from device-and procedure-related death through 30 days.
- freedom from target limb amputations and clinically driven target lesion revascularization through 6 months.
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
- •Clinically significant symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery;
- •Able and willing to provide informed consent prior to study procedures;
- •Able and willing to comply with follow-up requirements;
- •Rutherford Clinical Category of 2-4;
- •Resting ABI of <0.9 or abnormal exercise ABI;
- •≥18 years old;
- •Life expectancy is >2 year;
- •Angiographic Criteria:
- •Cumulative lesion length ≥4 and ≤15 cm within the target vessel; Cumulative lesion consists of either a single de novo lesion or multiple lesions within the 4-15 cm segment; multiple lesions require to meet all the following;
- •Separated by a gap of ≤ 3 cm;
- •Able to be treated as a single lesion;
- •Total combined lesion length including 3cm gap meets requirements;
- •Lesion location starts ≥2 cm distal to the common femoral bifurcation and terminates at ≥2 cm proximal to the origin of the tibio-peroneal trunk;
- •Clinically and hemodynamically significant de novo stenosis (>70% stenosis by visual estimate) or occlusion;
- •Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
- •Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
- •A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of ipsilateral iliac lesions); NOTE: Successful ipsilateral iliac artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.
- •At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized;
排除标准
- •Pregnant or lactating females;
- •Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries;
- •Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy;
- •Known intolerance to study medications, paclitaxel or contrast agents;
- •Patient participating in another investigational device or drug study that has not reached the primary endpoint;
- •History of hemorrhagic stroke within 2 months;
- •Previous or planned surgical or interventional procedure within 30 days of the study procedure;
- •Diagnosed liver failure, renal failure, chronic kidney disease, unstable angina pectoris, or myocardial infarction within 30 days of the procedure;
- •Presence of significant stenosis or occlusion of the inflow tract that cannot be successfully treated prior to study consideration. Successful is defined as <30% residual stenosis of ipsilateral iliac artery with no major complications;
- •Acute thrombus in target vessel;
- •At site of target lesion, use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, brachytherapy);
- •Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥50% stenosis) may not be treated during the same procedure;
- •Has in-stent restenosis in the target lesion;
- •Previous treatment with a drug coated PTA balloon catheter or drug eluting stent in the target vessel within 12 months of the index procedure;
- •Previous peripheral bypass affecting the target limb;
- •Has injuries in the target vessel, such as major flow-limiting dissection ( > NHLBI Grade C) and perforation, requiring stenting prior to enrollment;
- •Obvious subintimal recanalization or intentional subintimal recanalization in the occlusive lesions;
- •Presence of severe calcification in the target lesions that precludes endovascular treatment. Severe calcification is defined as circumferential calcification involving ≥ 50% of vessel diameter.
结局指标
主要结局
The primary outcome measure of the study is a composite of freedom from device and procedure related deaths through 30 days, freedom from target limb amputation, and clinically driven target lesion revascularization (TLR) through 6 months.
时间窗: 6 months
Clinically-driven target lesion revascularization is defined as a restenosis of 50% or more in the target lesion with worsening symptoms, OR more as 70% stenosis without symptoms.
次要结局
未报告次要终点
研究者
研究点 (6)
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