XTOSI Pilot Study: Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA) - Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety: Number of Patients with Freedom from Major Adverse Events (MAE) defined as composite of
研究概览
简要总结
This study postulates that the application of Sirolimus, an anti-proliferative agent that inhibits neointimal hyperplasia, via Sirolimus coated balloon (SCB) will be safe and will result in better arterial patency in infrainguinal peripheral arterial disease (PAD). The aim is to evaluate the efficacy (12 month freedom from clinically driven target lesion revascularisation) and safety (freedom from major adverse events) of sirolimus coated balloons in the treatment of infrainguinal PAD.
详细描述
It is imperative to have effective treatment strategies for PAD which can maintain the patency of arteries. The current standard of care for PAD is angioplasty which includes usage of drug coated balloons (DCB). Paclitaxel is the only anti-proliferative drug available in all currently available DCB technology. Sirolimus is another highly effective anti-proliferative drug of immense potential as demonstrated by superior results in Sirolimus drug eluting stents in coronary disease. The physical properties of Sirolimus have made it challenging for it to be similarly applied to DCB technology and it is only due to recent advances in nanotechnology that it is now possible to develop Sirolimus coated balloons (SCB), which is the study device used in this study. The study device allows delivery and deposition of sirolimus to the arterial wall. By applying this agent into lesions in peripheral arterial disease, this study aim to effectively reduce neointimal hyperplasia, and therefore prolong the patency of the artery and improve our limb salvage rates for PAD and CLI patients. Subjects will be followed up in the clinic at 6 month, 12 month, and 24 month post-intervention to assess primary and secondary outcome of safety and efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years or minimum age
- •Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable
- •Lesion(s) in the infrainguinal arteries between 3 to 6mm which are suitable for endovascular treatment treated with the Xtreme Touch - Neo sirolimus PTA balloon catheter. For below the knee (BTK) arteries, lesions located in the proximal 200mm of the artery.
排除标准
- •Life expectancy ≤ 1 year
- •Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet
- •Subject is pregnant or planning to become pregnant during the course of the study
- •Failure to achieve less than 30% residual stenosis in pre-existing lesion after plain balloon angioplasty
- •Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations
结局指标
主要结局
Safety: Number of Patients with Freedom from Major Adverse Events (MAE) defined as composite of
时间窗: 6 months
1. freedom from device- and procedure-related mortality, and major target limb amputation through to 30 days, and 2. Freedom from clinically driven target lesion revascularization (TLR) within 6 months post-index procedure.
Efficacy: Number of Patients with Primary patency
时间窗: 6 months
Defined as by duplex ultrasonography-derived peak systolic velocity ratio of \< = 2.4
次要结局
- Number of Patients with Amputation-free survival(6, 12 and 24 months)
- Number of Patients with Freedom from clinically-driven TVR(6 and 24 months)
- Number of Patients with Primary patency(12 and 24 months)
- Number of Patients with Improvement in Rutherford classification(6, 12 and 24 months)
- Number of Patients with Device success(Day 0)
- Number of Patients with Technical success(Day 0)
- Number of Patients with Procedural success(Participants will be followed for the duration of hospital stay, an expected average of 1-2 days)
- Number of Patients with Freedom from clinically-driven TLR(6, 12, and 24 months)
- Number of Patients with Freedom from MAE(12 and 24 months)