First in Human Evaluation of the Drug-Coated Chocolate Balloon for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Late Lumen Loss (LLL)
研究概览
简要总结
This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease. The study focuses on acute device performance and peri-procedural safety and also seeks to further characterize the performance of the device.
详细描述
This is a prospective, multi-center, single-arm study. Symptomatic lower extremity Peripheral Arterial Disease (PAD) patients presenting for endovascular revascularization will be enrolled in the study if they meet all entry criteria. The study will include patients from New Zealand and the European Union. The endpoints were designed to establish safety of the DCC and to identify long-term clinical benefits of this technology.
The patients treated in this study will be designated into the above the knee (ATK) follow-up schedule if they are treated with the DCC in the SFA or Popliteal vessels. This schedule calls for clinical visits with duplex ultrasounds at 1,6 and 12 months. Patients will be designated into the below the knee (BTK) follow-up schedule if they are treated with the DCC in the Peroneal, Anterior Tibial, Posterior Tibial or Pedal vessels. These patients will have clinical visits at 1, 3 and 6 months with duplex ultrasound at the 1 and 6 months visits only.
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
- •Intermittent claudication or critical limb ischemia
- •Atherosclerotic target lesion >70% stenosis
- •Reference vessel diameter (RVD) between 2.0 and 6.0mm
- •Angiographic evidence of distal run-off
- •Target lesion length <150mm that consists of no more than two adjacent lesions( < 25mm apart) and is able to be completely covered with inflation of no more than two DCC devices
排除标准
- •Acute limb ischemia or thrombolytic therapy
- •Known and relevant allergies/hypersensitivities
- •Known impaired renal function
- •Known bleeding disorder
- •Severe calcification at the target lesion
- •Previous bypass or stent at, or proximal to, target vessel
- •Aneurysm in target limb
- •Prior major limb amputation
- •Use of a any of the following: re-entry device, atherectomy, laser or other ablation procedure, or cutting/scoring balloon at the target lesion; use of drug eluting stent, or non-study drug coated balloon in the target limb.
结局指标
主要结局
Late Lumen Loss (LLL)
时间窗: 3 Months (BTK) or 6 Months (ATK)
LLL is determined by assessing the difference between the minimum lumen diameter (MLD) immediately after treatment with the DCC and the MLD at angiographic follow-up. LLL will determined by the Angiographic Core Laboratory.
次要结局
- Device Success(approx 1 hour)
- Device Related Adverse Events (AEs)(30 days)
- Technical Success(approx 1 hour)
- Freedom from Target Lesion Revascularization (TLR)(30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only))
- Amputation Free Survival(30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only))
- Patency(6 Months / 12 Months (ATK only))