A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 14
- 主要终点
- Achievement of Optimal PTA in Percent
研究概览
简要总结
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis
详细描述
This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate achievement of optimal PTA dilatation. A total of 188 patients will be enrolled from 14 sites in China. All patients enrolled will be assigned to the test group (DKutting LL balloon, n=94) and the control group (Chocolate balloon, n=94) with randomized allocation ratio of 1:1.
Primary endpoint is percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved. A 30-day after procedure follow-up will be conducted for all 188 patients.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 year-old male & non-pregnant female
- •Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery.
- •Rutherford clinical category-Becker class: 2 to 5
- •Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study.
- •Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplasty
- •Reference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm; Total length of osculation lesion is less than 100mm
- •Only one target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The number non-target lesions are limited to maximum 3.
排除标准
- •Acute or sub-acute thrombosis exist in target lesion
- •Severe calcified lesion (PACSS Grading 4)
- •Guidewire cannot cross target lesion
- •Amputation planned within 30 days
- •In-stent restenosis
- •Flow-limiting dissection (NHLBI grading: D-F) occurred in target lesion by pre-dilation
- •No other lumen-reduction devices (such as: cutting balloon, dual-wire balloon, Hawk, ELCA etc.) are treated before or after test/control group treatment.
- •Before test/control group treatment, target lesion was expanded by Antegrade Dissection Re-entry (ADR) technique.
- •Patient who cannot accept anticoagulant or antiplatelet therapy
- •Aware of patient allergic to heparin, contrast, aspirin and clopidogrel, anesthetics
- •Patients who have not completed clinical trials of other drugs or devices
- •Patients with poor compliance and unable to complete the study, which is identified by investigator.
结局指标
主要结局
Achievement of Optimal PTA in Percent
时间窗: 1 day
Percentage of PTA cases in which \<30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F). Residual stenosis in percent and dissection NHLBI grading are accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. \[0-100%, higher the better\]
次要结局
- Device Success Rate in Percent(1 day)
- Numerical Ankle Brachial Index(0-7days)
- Freedom from clinical-driven TLR rate in percent(30+/-7 Days post procedure)
- Rutherford Grading Reduction in percent(30+/-7 Days post procedure)
- Freedom from Amputation above ankle rate in percent(30+/-7 Days post procedure)
- Numerical Acute Lumen Gain in mm(1 day)
- Technical Success Rate in percent(0-7 days)