NCT02137577已完成不适用
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of the Infrapopliteal Artery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Primary Patency [Time Frame: 6 months]
研究概览
简要总结
The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.
详细描述
PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.
DEBs are designed to promote arterial patency by reducing neointimal proliferation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years
- •Patients with peripheral artery disease (PAD), with Rutherford classification between 4 and 6
- •an occlusion or a minimum grade of stenosis Primary over 70% in the below popliteal artery
- •The expected survival time is more than 1 year
- •signed Patient informed consent form
排除标准
- •Serum creatinine clearance rate less than 30ml/min in patients
- •patients with acute thrombosis requiring lysis or thrombectomy
- •patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
- •patient requiring intervention in both lower limbs at the same time
- •In-stent restenosis in the blow-knee popliteal artery
- •target lesion can't be cross by the guide wire
- •the stenosis rate of proximal outflow more than 30% with or without intervention
- •the length of the stenosis or occlusion in proximal outflow(including the Iliac artery, the superficial femoral artery, the Popliteal artery) more than 150mm before intervention
- •stenosis or occlusion of distal outflow for below-the-ankle artery.
- •expected major amputations at the index limb before intervention
- •known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
- •patients participating in another clinical trials with interfere with this trial in the same time
- •pregnancy and lactating woman
- •untreatable bleeding diatheses
结局指标
主要结局
Primary Patency [Time Frame: 6 months]
时间窗: 6 months
Freedom from target vessel occlusion and clinically driven target lesion reintervention
次要结局
- Ulcer healing rate(6 months, 12 months)
- device success rate(during the operation(after using the DEB catheter))
- technical success rates(during the operation(after using the DEB catheter))
- if occured clinically driven TLR( target lesion revascularization)(6 months, 12 months,18 months, 24 months)
- target lesion late lumen loss 6 months(6 months)
- Ulcer healing time(6 months, 12 months, 18 months, 24 months)
- operation success rate(during the operation(after using the DEB catheter))
- limb salvage in surviving subjects(30 days, 6 months, 12 months,18 months, 24 months)
- Change from baseline ankle brachial index(ABI) at 6 months(6 months)
- change from baseline Rutherford stage at 6 months(6 months, 12 months,18 months, 24 months)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
AcoArt Ⅰ / SFA ChinaPeripheral Artery DiseaseNCT01850056Acotec Scientific Co., Ltd200
已完成
不适用
AcoArt VI / Vertebral Artery Ostium Stenosis in ChinaIschemic StrokeTransient Ischemic AttackNCT03910166Acotec Scientific Co., Ltd180
进行中（未招募）
不适用
STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) TrialDrug-coated BalloonDrug-eluting StentDe Novo StenosisNCT06084000China National Center for Cardiovascular Diseases2,700
已完成
3 期
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Osteoarthritic PainPainOsteoarthritisNCT00345787Mundipharma K.K.262
已完成
3 期
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back PainLow Back PainNCT00346047Mundipharma K.K.238