A Post Market Clinical Study to Evaluate the Clinical Safety and Performance of Peripherics Paclitaxel-coated Balloon Catheter in the Treatment of Below-the-Knee Arteries
试验速览
- 阶段
- Unknown
- 状态
- Other (Terminated)
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Major Adverse Limb Events (MALE) with perioperative all-cause death
研究概览
简要总结
Peripheral Arterial Disease (PAD) occurs when a narrowing, or blockage, develops in the arteries; PAD most commonly affects the legs. Endovascular options are frequently performed as the first line of therapy in patients with chronic limb-threatening ischemia. The endovascular treatment landscape encompasses a broad range of interventions, and each option has unique advantages and disadvantages. Drug-coated balloons (DCBs) were developed to address some of these concerns, and numerous randomized controlled trials (RCTs) have demonstrated that DCBs are safe and more effective for the treatment of patients with below the knee arteries during routine clinical practice.
The treatment strategy will be determined by the Investigator. It is recommended that each enrolling investigator review Peripherics paclitaxel-coated balloon catheter Instructions for Use and assess the contraindications, warnings, and precaution sections with respect to risks and benefits for treating potential patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Rutherford Clinical Category 3-5 Significant stenosis or occlusion of one or two native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment Patient is willing to provide informed consent, and is willing to comply with the protocol required follow-up visits and recommended medication regimen.
排除标准
- •Life expectancy of less than 1-year Lesions and/or occlusions located or extending into the popliteal artery or below the ankle joint space.
- •Inflow lesion or occlusion in the ipsilateral Iliac, superficial femoral artery (SFA), popliteal arteries with a length equal to or above 15 cm.
- •Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.
- •Known allergy to concomitant medication, paclitaxel, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant, or thrombolytic medications.
- •Patient with any medical condition that would make him/her inappropriate for treatment with Peripherics paclitaxel-coated balloon catheter as per the current IFU or in the opinion of the Investigator Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure Patients with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk for major amputation Evidence of aneurysm or acute thrombus in the target vessel(s) Previously implanted stent in target lesion(s) Previous procedure with drug-coated balloons in the target vessel(s) within 6 months prior to index procedure Presence of concentric calcification that precludes adequate vessel preparation as per the current IFU Patients confined to bed that are completely non-ambulatory.
结局指标
主要结局
Major Adverse Limb Events (MALE) with perioperative all-cause death
时间窗: 30 days
次要结局
- Major Adverse Events (MAE)(12 months)
研究者
Dr Varinder Singh Bedi
Sir Ganga Ram Hospital