A Prospective, Multicenter, Single Arm, Post-Market Study to Assess the Clinical Safety and Performance of Peripherics Paclitaxel-coated PTA Balloon Catheter in Superficial Femoral and Popliteal Arteries
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- Freedom from Major Adverse Events (MAE)
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 SFA/PA than uncoated balloon angioplasty. This study is to assess the clinical safety and performance of Peripherics paclitaxel coated PTA balloon catheter in superficial femoral artery and/or popliteal artery during routine clinical practice.
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
- •Age ≥ 18 years
- •Patient with documented diagnosis of peripheral arterial disease in SFA and/or PA classified as Rutherford class 3-5
- •Lesion(s) in SFA and/or PA suitable for endovascular treatment, scheduled to be treated with Peripherics paclitaxel-coated PTA balloon catheter according to Instructions For Use (IFU) Allowed lesion location: Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the Tibioperoneal (TP) trunk.
- •Target lesion(s) must either be de-novo or non-stented re-stenotic lesion(s).
- •If the target lesion(s) is re-stenotic, the prior PTA must have been done more than 30 days prior-index procedure
- •Target lesion(s) can be treated with available Peripherics paclitaxel-coated PTA balloon catheter’s size matrix per the current IFU
- •Patient provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site
- •Patient agrees to comply with the protocol-mandated follow-up procedures and visits
- •At least one native artery with direct outflow artery to the foot.
排除标准
- •Life expectancy of less than 1 year
- •Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet
- •Patient is pregnant or planning to become pregnant during the course of the study
- •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 PTA balloon catheter as per the current IFU or in the opinion of the Investigator
- •Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
- •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.
结局指标
主要结局
Freedom from Major Adverse Events (MAE)
时间窗: 30 days
Freedom from MAE defined as, a composite of freedom from all-cause mortality, freedom from major target limb amputation, and freedom from clinically
时间窗: 30 days
driven target lesion revascularization (CD-TLR)
时间窗: 30 days
次要结局
- 1.Freedom from Major Adverse Events(2. Primary patency. Primary patency defined as freedom from CD-TLR and freedom from)
研究者
Dr P C Gupta
CARE Hospitals