NCT04885985招募中不适用
A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Primary Patency
研究概览
简要总结
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and ≤75 years old
- •Rutherford clinical category classification：3,4 or 5
- •Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
- •Reference vessel diameter is between 2 mm and 4 mm
- •Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
排除标准
- •Plasma creatinine clearance rate <30 mL/min
- •Acute vessel occlusion or acute thrombosis in target lesion
- •Planned amputation on the target limb
- •Subjects confined to bed that are completely non-ambulatory.
- •Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
- •Life expectancy < 5 year.
- •Cumulative length of 100% occluded target lesion(s)>150 mm
- •In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm
- •History of stroke within 90 days prior to enrollment
- •Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
- •Uncorrectable bleeding diathesis
- •The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery
- •Pregnant or breastfeeding female subjects
- •Ability to cross a guidewire through target lesion
- •Patients who have participated in clinical trials of other medical devices or drugs during the same period
结局指标
主要结局
Primary Patency
时间窗: 6 month
Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.
次要结局
- Rate of All-cause mortality(12 months,24 months,36 months,48 months ,60 months)
- Major adverse event (MAE) rate(30 days)
- Rate of clinically-driven target vessel revascularization (CD-TVR)(12 months,24 months,36 months,48 months ,60 months)
- Patency rate(12 months,24 months,36 months,48 months ,60 months)
- Rate of clinically-driven target lesion revascularization (CD-TLR)(12 months,24 months,36 months,48 months ,60 months)
- Rate of ulcer healing(12 months,24 months,36 months,48 months ,60 months)
- Rate of major target limb amputation(12 months,24 months,36 months,48 months ,60 months)
- Rate of distal embolization(through procedure completion)
研究者
研究点 (1)
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